Measles, mumps, rubella, and varicella virus vaccine live (Subcutaneous, Intramuscular)

Measles, mumps, rubella, and varicella virus vaccine (live) is a vaccine that helps protect against infections from the measles (rubeola), mumps, rubella (German measles), and varicella (chickenpox) viruses. This combination vaccine works by helping your body create its own protection (antibodies) against these viruses.

Measles (also known as coughing measles, hard measles, morbilli, red measles, rubeola, and 10-day measles) is a highly contagious infection. It can lead to serious complications, such as stomach problems, pneumonia, ear infections, sinus issues, convulsions (seizures), brain damage, and possibly death. The risk of severe complications and death is higher for adults and infants compared to children and teenagers.

Mumps is an infection that can lead to serious issues, including encephalitis and meningitis, which affect the brain. Teenage boys and men are particularly at risk for a condition called orchitis, which causes pain and swelling in the testicles and scrotum, and in rare cases, can lead to sterility. Mumps infection can also cause spontaneous abortion (miscarriage) in women during the first 3 months of pregnancy.

Rubella (also known as German measles) is a serious infection that can result in miscarriages, stillbirths, or birth defects in unborn babies if pregnant women contract the disease.

Varicella (commonly known as chickenpox) is a contagious infection. Chickenpox is usually mild but can sometimes lead to serious complications, such as pneumonia, brain inflammation, and a rare condition called Reye's syndrome.

This vaccine must be given only by or under the supervision of your doctor or another healthcare professional.

It is very important that your child returns to your doctor’s office at the right time if they need a second dose of the vaccine. Be sure to tell your doctor about any side effects that happen after your child receives this vaccine.

Do not become pregnant for 3 months after receiving this vaccine without first checking with your doctor. There is a chance that this vaccine may cause problems during pregnancy. If you think you might be pregnant, tell your doctor right away.

This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical help. Tell your doctor right away if you have a rash, itching, a fast heartbeat, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving the vaccine.

Proquad® injection will lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Children who have received this vaccine have developed a fever and, in some cases, a fever with seizures. Talk with your child's doctor if you have concerns about this.

Your child should avoid close contact with people at high risk for catching the varicella virus for 6 weeks after receiving this vaccine. People who are at risk for catching the virus are pregnant women, newborn babies, and anyone who has a weak immune system that makes it hard for them to fight infections.

Tell your doctor that you have received this vaccine:

• If you are to receive blood transfusions or other blood products within 3 months of receiving this vaccine.
• If you are to receive varicella-zoster immune globulin (VZIG) or other immune globulins within 3 to 5 months after receiving this vaccine.
• If you are to have a tuberculin skin test within 4 to 6 weeks after receiving this vaccine.
• If you are to receive any other live virus vaccines within 1 or 3 months of receiving this vaccine.

Do not take aspirin or medicines that contain aspirin (such as cold medicines) for 6 weeks after receiving this vaccine. Carefully check the label of any pain, headache, or cold medicine you give to your child to make sure it does not contain aspirin or salicylic acid.

This vaccine contains albumin, which comes from human blood. Some human blood products have transmitted certain viruses (for example, Creutzfeldt-Jakob Disease) to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is due to required testing of human donors for certain viruses, and testing during the manufacture of these medicines. Although the risk is low, talk with your child's doctor if you have concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a vaccine, you and your doctor need to consider the risks of the vaccine compared to the benefits it provides. For this vaccine, the following points should be taken into account:

Allergies

Inform your doctor if you have ever experienced any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare provider know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

This vaccine is not recommended for infants younger than 12 months or for children 13 years of age and older. Its safety and effectiveness have not been established for these age groups.

Geriatric

This vaccine is not recommended for elderly patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a chance of interaction. In these situations, your doctor may need to adjust the dose or take other precautions. When receiving this vaccine, it is especially important for your healthcare provider to know if you are taking any of the medicines listed below. The following interactions are particularly significant and do not include all possible interactions.

Receiving this vaccine with any of the following medicines is not recommended. Your doctor may decide to avoid using this vaccine or adjust some of the other medicines you are taking.

• Alemtuzumab
• Bendamustine
• Bortezomib
• Bosutinib
• Cabazitaxel
• Capecitabine
• Carboplatin
• Carfilzomib
• Carmustine
• Chlorambucil
• Cisplatin
• Cladribine
• Clofarabine
• Cyclophosphamide
• Cytarabine
• Cytarabine Liposome
• Dacarbazine
• Dasatinib
• Daunorubicin
• Daunorubicin Citrate Liposome
• Daunorubicin Liposome
• Deflazacort
• Docetaxel
• Doxorubicin
• Epirubicin
• Etoposide
• Fludarabine
• Fluorouracil
• Gemcitabine
• Gemtuzumab Ozogamicin
• Hydroxyurea
• Idarubicin
• Ifosfamide
• Imatinib
• Interferon Alfa
• Irinotecan
• Irinotecan Liposome
• Lomustine
• Mechlorethamine
• Melphalan
• Mercaptopurine
• Methotrexate
• Mitomycin
• Mitoxantrone
• Nelarabine
• Nilotinib
• Ofatumumab
• Oxaliplatin
• Paclitaxel
• Paclitaxel Protein-Bound
• Pemetrexed
• Pentostatin
• Ponatinib
• Procarbazine
• Rituximab
• Temozolomide
• Teniposide
• Thiotepa
• Topotecan
• Tositumomab
• Vinblastine
• Vinorelbine

Receiving this vaccine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Adalimumab
• Anifrolumab-fnia
• Ansuvimab-zykl
• Antithymocyte Globulin Rabbit
• Aspirin
• Atoltivimab
• Axicabtagene Ciloleucel
• Azathioprine
• Baricitinib
• Belatacept
• Benorilate
• Betibeglogene Autotemcel
• Bimekizumab-bkzx
• Brexucabtagene Autoleucel
• Brodalumab
• Canakinumab
• Certolizumab Pegol
• Choline Salicylate
• Cyclosporine
• Deucravacitinib
• Dupilumab
• Efgartigimod Alfa-fcab
• Elivaldogene Autotemcel
• Emapalumab-lzsg
• Etanercept
• Etrasimod
• Everolimus
• Fingolimod
• Golimumab
• Guselkumab
• Hyaluronidase
• Immune Globulin
• Inebilizumab-cdon
• Infliximab
• Ixekizumab
• Leflunomide
• Leniolisib
• Meningococcal Vaccine
• Mesalamine
• Mirikizumab-mrkz
• Mycophenolic Acid
• Ocrelizumab
• Olsalazine
• Ozanimod
• Ponesimod
• Rilonacept
• Risankizumab-rzaa
• Ritlecitinib
• Rozanolixizumab-noli
• Salicylamide
• Salicylic Acid
• Salsalate
• Sarilumab
• Satralizumab-mwge
• Secukinumab
• Siponimod
• Sirolimus
• Sodium Salicylate
• Sodium Thiosalicylate
• Spesolimab-sbzo
• Tacrolimus
• Teplizumab-mzwv
• Teriflunomide
• Tildrakizumab-asmn
• Tocilizumab
• Tofacitinib
• Trabectedin
• Tralokinumab-ldrm
• Trolamine Salicylate
• Ublituximab-xiiy
• Upadacitinib
• Ustekinumab
• Valoctocogene Roxaparvovec-rvox
• Vamorolone
• Voclosporin

Receiving this vaccine with any of the following medicines may increase the risk of certain side effects, but using both may be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Abatacept
• Cytomegalovirus Immune Globulin, Human
• Hepatitis B Immune Globulin
• Rabies Immune Globulin
• Respiratory Syncytial Virus Immune Globulin, Human
• Tetanus Immune Globulin
• Vaccinia Immune Globulin, Human
• Varicella-Zoster Immune Globulin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at the same time as food or certain types of food, as interactions may occur. Alcohol or tobacco can also interact with certain medicines. Discuss with your healthcare provider about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect the use of this vaccine. Make sure to inform your doctor about any other medical issues, especially:

• Allergy to eggs, history of—This may increase the risk of a serious allergic reaction happening again.

• Brain injury or
• Seizures, history of or
• Thrombocytopenia (not enough platelets in the blood) or history of—Use with caution, as it may worsen these conditions.

• Severe immune system problems or
• Active and untreated tuberculosis—This vaccine should not be used in patients with this condition.

Along with its necessary effects, a medicine may also cause some unwanted effects. Not all of these side effects will happen, but if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Fever over 39 °C (102 °F)

Less common

• Body aches or pain
• Chills
• Cough
• Ear congestion
• Fever
• Headache
• Loss of voice
• Rash that looks like chickenpox or measles
• Sneezing
• Sore throat
• Stuffy or runny nose
• Unusual tiredness or weakness

Incidence not known

• Agitation
• Sudden and severe back pain
• 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 or tightness
• Confusion
• Cough or hoarseness
• Cough producing mucus
• Diarrhea
• Difficulty breathing
• Difficulty 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 on the skin
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Loss of appetite
• Loss of consciousness
• Lower back or side pain
• Mood or mental changes
• Muscle aches and pains
• Sudden and progressing muscle weakness
• 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 walking
• Shakiness in the legs, arms, hands, or feet
• Shivering
• 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, 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
• 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
• Sudden and severe weakness in the arm or leg on one side of the body
• Weakness of the muscles in your face
• White patches in the mouth or throat or on the tongue
• White patches with diaper rash

Some side effects may occur that usually do not need medical attention. These side effects may go away as your body adjusts to the medicine. Also, your health care professional may be able to tell you how 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

Incidence not known

• Abnormal dreams
• Blindness
• Bloated
• Blue-yellow color blindness
• Deafness
• Decreased vision
• Difficulty 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

A nurse or other trained health professional will give your child this vaccine. It is given as a shot under your skin (usually in the upper arms or thighs) or into one of your muscles.

This vaccine is given in 2 doses. First dose is given at 12 to 15 months of age, while the second dose is given at 4 to 6 years of age.

Your child may receive certain other vaccines at the same time as this one, but in a different body area.

This vaccine comes with patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions..

It is important to receive this vaccine at the proper time. If your child misses a scheduled shot, call your child's doctor to make another appointment as soon as possible.