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ProQuad Side Effects

Generic Name: measles virus vaccine / mumps virus vaccine / rubella virus vaccine / varicella virus vaccine

Note: This page contains side effects data for the generic drug measles virus vaccine / mumps virus vaccine / rubella virus vaccine / varicella virus vaccine. It is possible that some of the dosage forms included below may not apply to the brand name ProQuad.

It is possible that some side effects of ProQuad may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

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

As well as its needed effects, measles virus vaccine / mumps virus vaccine / rubella virus vaccine / varicella virus vaccine may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking measles virus vaccine / mumps virus vaccine / rubella virus vaccine / varicella virus vaccine, check with your doctor immediately:

More common
  • Fever over 39 °C (102 °F)
Less common
  • Body aches or pain
  • chills
  • cough
  • ear congestion
  • fever
  • headache
  • loss of voice
  • nasal congestion
  • rash that looks like chickenpox or measles
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness
Incidence not known
  • Agitation
  • back pain, sudden and severe
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blood in the urine or stools
  • bloody nose
  • bloody or black, tarry stools
  • blurred vision
  • burning or stinging of the skin
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain
  • coma
  • confusion
  • cough or hoarseness
  • cough producing mucus
  • diarrhea
  • difficulty with breathing
  • difficulty with swallowing
  • dizziness
  • drowsiness
  • fainting
  • fast heartbeat
  • general feeling of discomfort or illness
  • hallucinations
  • hives
  • inability to move the arms and legs
  • inability to speak
  • irritability
  • itching, pain, redness, swelling, tenderness, or warmth on the skin
  • joint or muscle pain
  • large, flat, blue, or purplish patches in the skin
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • lower back or side pain
  • mood or mental changes
  • muscle aches and pains
  • muscle weakness, sudden and progressing
  • nausea
  • noisy breathing
  • numbness, tingling, pain, or weakness in the hands or feet
  • pain, numbness, or tingling of the hands, arms, legs, or feet
  • pain, tenderness, or swelling in the testicles and scrotum
  • painful blisters on the trunk of the body
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • painful knees and ankles
  • painful or difficult urination
  • 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, buttocks, legs, or ankles
  • rapid weight gain
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • seizures
  • severe or sudden headache
  • shakiness and unsteady walk
  • shakiness in the legs, arms, hands, or feet
  • shivering
  • shortness of breath
  • skin rash
  • skin rash on the face, scalp, or stomach
  • slurred speech
  • sores, ulcers, or white spots on the lips or in the mouth
  • stiff neck or back
  • stomach pain
  • sudden numbness and weakness in the arms and legs
  • sweating
  • swelling or puffiness of the face
  • swollen or painful glands
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • swollen, painful, or tender lymph glands on the side of the face or neck
  • temporary blindness
  • tenderness
  • thickening of bronchial secretions
  • tightness in the chest
  • tingling of the hands or feet
  • trembling or shaking of the hands or feet
  • trouble sleeping
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual bleeding or bruising
  • unusual weight gain or loss
  • vomiting
  • warmth on the skin
  • weakness in the arm or leg on one side of the body, sudden and severe
  • weakness of the muscles in your face
  • wheezing
  • white patches in the mouth or throat or on the tongue
  • white patches with diaper rash

Some measles virus vaccine / mumps virus vaccine / rubella virus vaccine / varicella virus vaccine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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
Incidence not known
  • Abnormal dreams
  • blindness
  • bloated
  • blue-yellow color blindness
  • deafness
  • decreased vision
  • difficulty with moving
  • double vision
  • ear pain
  • excess air or gas in the stomach or intestines
  • eye pain
  • full feeling
  • irritation and swelling of the eyelids
  • lack of feeling or emotion
  • muscle or bone pain
  • muscle pain or stiffness
  • nervousness
  • pain and swelling in the scrotum
  • pain in the hip, leg, or neck
  • pain or tenderness around the eyes and cheekbones
  • passing gas
  • red rash with watery, yellow-colored, or pus filled blisters
  • thick yellow to honey-colored crusts
  • uncaring
  • unusually deep sleep
  • unusually long duration of sleep

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

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]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. ProQuad (measles/mumps/rubella/varicella virus vaccine)." Merck & Company Inc, West Point, PA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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