"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
- Patient Information:
Details with Side Effects
Children 12 to 23 Months of Age
ProQuad (measles mumps rubella varicella vaccine live) was administered to 4497 children 12 to 23 months of age in clinical trials without concomitant administration with other vaccines. The safety of ProQuad (measles mumps rubella varicella vaccine live) was compared with the safety of M-M-R II and VARIVAX given concomitantly at separate injection sites. The safety profile for ProQuad (measles mumps rubella varicella vaccine live) was similar to the component vaccines. Children in these studies were monitored for up to 42 days post- vaccination. The only systemic vaccine-related adverse experiences that were reported at a significantly greater rate in individuals who received ProQuad (measles mumps rubella varicella vaccine live) than in individuals who received M-M-R II and VARIVAX concomitantly at separate injection sites were fever ( ≥ 102°F [ ≥ 38.9°C] oral equivalent or abnormal) (21.5% versus 14.9%, respectively), and measles-like rash (3.0% versus 2.1%, respectively). Both fever and measles-like rash usually occurred within 5 to 12 days following the vaccination, were of short duration, and resolved with no long-term sequelae. Pain/tenderness/soreness at the injection site was reported at a statistically lower rate in individuals who received ProQuad (measles mumps rubella varicella vaccine live) than in individuals who received M-M-R II and VARIVAX concomitantly at separate injection sites (22.0% versus 26.7%, respectively). The only vaccine-related injection-site adverse experience that was more frequent among recipients of ProQuad (measles mumps rubella varicella vaccine live) than recipients of M-M-R II and VARIVAX was rash at the injection site (2.3% versus 1.5%, respectively). Table 1 summarizes the frequencies of injection-site and systemic adverse experiences that were reported as vaccine related by the investigator among > 1% of children in these clinical trials.
Table 1: Vaccine-Related Injection-Site and Systemic Adverse
Experiences Reported in 21 % of Children Who Received 1 Dose of ProQuad (measles mumps rubella varicella vaccine live) or M-M-R
II and VARIVAX at 12 to 23 Months of Age (0-42 Days Postvaccination)
|Adverse Experiences|| ProQuad (measles mumps rubella varicella vaccine live)
(N = 4497)
| M-M-R II and VARIVAX
(N = 2038)
|Fever ≥ 102°F ( ≥ 38.9°C)‡§||21.5||14.9|
|Rash (not otherwise specified)||1.6||1.4|
|Upper respiratory infection||1.3||1.1|
| † Injection-site adverse
experiences for M-M-R II and VARIVAX are based on occurrence with either
of the vaccines administered.
‡ Designates a solicited adverse experience. Injection-site adverse experiences were solicited only from Days 0-4 postvaccination.
§ Temperature reported as oral equivalent or abnormal.
The following additional vaccine-related clinical adverse experiences (incidence ≥ 0.2% but < 1%) were observed in individuals following a single dose of ProQuad (measles mumps rubella varicella vaccine live) . Solicited adverse experiences are designated with the symbol (‡).
Metabolism and nutrition disorders: anorexia.
Nervous system disorders: somnolence.
Gastrointestinal disorders: vomiting.
Skin and subcutaneous tissue disorders: miliaria rubra, rubella-like rash*.
General disorders and administration site conditions: malaise.
The following additional adverse events have been reported with ProQuad (measles mumps rubella varicella vaccine live) in post-marketing experience.
Immune system disorders: anaphylactic reaction.
Skin and subcutaneous tissue disorders: pruritus.
Adverse Experiences after vaccination with M-M-RII or VARIVAX
Other adverse experiences have been reported in clinical studies and with marketed use of either M-M-R II, the monovalent component vaccines of M-M-R II, or VARIVAX. These adverse effects are listed below without regard to causality or frequency.
Infections and infestations
Blood and the lymphatic system disorders
Lymphadenitis, regional lymphadenopathy, thrombocytopenia.
Immune system disorders
Agitation, apathy, nervousness.
Nervous system disorders
Afebrile convulsions or seizures, aseptic meningitis (see below), Bell's palsy, cerebrovascular accident, dizziness, dream abnormality, encephalitis (see below), encephalopathy (see below), Guillain- Barre syndrome, headache, hypersomnia, measles inclusion body encephalitis (see CONTRAINDICATIONS), ocular palsies, paraesthesia, polyneuritis, polyneuropathy, subacute sclerosing panencephalitis (see below), syncope, transverse myelitis, tremor.
Ear and labyrinth disorders
Respiratory, thoracic and mediastinal disorders
Skin and subcutaneous tissue disorders
General disorders and administration site conditions
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, lip abnormality, papillitis, roughness/dryness, stiffness, trauma, varicella-like rash, venipuncture site hemorrhage, warm sensation, warm to touch.
The discussion that follows describes adverse reactions which have been identified post-approval for the monovalent components of ProQuad (measles mumps rubella varicella vaccine live) . Because these reactions are described in the literature or reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship.
Death from various, and in some cases unknown, causes has been reported rarely 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. However, there were no deaths or permanent sequelae reported in a published post-marketing surveillance study in Finland involving 1.5 million children and adults who were vaccinated with M-M-R II during 1982 to 1993.16
Encephalitis and encephalopathy have been reported approximately once for every 3 million doses of the combination of measles, mumps, and rubella vaccine contained in M-M-R II. Post-marketing surveillance of the more than 400 million doses that have been distributed worldwide (1978 to 2003) indicates that serious adverse events such as encephalitis and encephalopathy continue to be rarely reported. In no case has it been shown conclusively that reactions were actually caused by the vaccine; however, the data suggest the possibility that some of these cases may have been caused by measles vaccines. The risk of such serious neurological disorders following live measles virus vaccine administration remains far less than that for encephalitis and encephalopathy with wild-type measles (1 per 2000 reported cases).
Arthralgia and/or arthritis (usually transient and rarely chronic), and polyneuritis are features of infection with wild-type rubella and vary in frequency and severity with age and gender, being greatest in adult females and least in prepubertal children. Following vaccination in children, reactions in joints are generally uncommon (0 to 3%) and of brief duration. In women, incidence rates for arthritis and arthralgia are generally higher than those seen in children (12 to 26%), and the reactions tend to be more marked and of longer duration. Symptoms may persist for a matter of months or on rare occasions for years. In adolescent girls, the reactions appear to be intermediate in incidence between those seen in children and adult women. In women 35 to 45 years old these reactions are generally well tolerated and rarely interfere with normal activities.
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. Only rarely have vaccine recipients developed chronic joint symptoms.
There have been reports of subacute sclerosing panencephalitis (SSPE) in children who did not have a history of infection with wild-type measles but 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. This is far less than the association with infection with wild-type measles, 6 to 22 cases of SSPE per million cases of measles. The results of a retrospective case-controlled study suggest that the overall effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent higher risk of SSPE.
Cases of aseptic meningitis have been reported to VAERS 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™ mumps vaccine to aseptic meningitis.
The reported rate of zoster in recipients of VARIVAX appears not to exceed that previously determined in a population-based study of healthy children who had experienced wild-type varicella.17 In clinical trials, 8 cases of herpes zoster were reported in 9454 vaccinated individuals 12 months to 12 years of age during 42,556 person-years of follow-up. This resulted in a calculated incidence of at least 18.8 cases per 100,000 person-years. All 8 cases reported after VARIVAX were mild and no sequelae were reported. The long-term effect of VARIVAX on the incidence of herpes zoster is unknown at present.
Read the Proquad (measles mumps rubella varicella vaccine live) Side Effects Center for a complete guide to possible side effects
Immune Globulins and Transfusions
Immune globulins administered concomitantly with ProQuad (measles mumps rubella varicella vaccine live) may interfere with the expected immune response. Vaccination should be deferred for at least 3 months following blood or plasma transfusions, or administration of immune globulins (IG).
The appropriate suggested interval between transfusion or IG administration and vaccination will vary with the type of transfusion or indication for, and dose of, IG (e.g., 5 months for Varicella Zoster Immune Globulin rVZIG]).11 Following administration of ProQuad (measles mumps rubella varicella vaccine live) , any immune globulin (IG) including VZIG should not be given for 1 month thereafter unless its use outweighs the benefits of vaccination.11
Reye's syndrome has been reported following the use of salicylates during wild-type varicella infection. Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with ProQuad (measles mumps rubella varicella vaccine live) .
Corticosteroids and Immunosuppressive Drugs
ProQuad (measles mumps rubella varicella vaccine live) may be used in individuals who are receiving topical corticosteroids or low-dose corticosteroids for asthma prophylaxis or replacement therapy, e.g., for Addison's disease. ProQuad (measles mumps rubella varicella vaccine live) should not be given to individuals receiving immunosuppressive doses of corticosteroids or other immunosuppressive drugs.
Drug/Laboratory Test Interactions
Live attenuated measles, mumps, and rubella virus vaccines given individually may result in a temporary depression of tuberculin skin sensitivity. Therefore, if a tuberculin test is to be done, it should be administered either any time before, simultaneously with, or at least 4 to 6 weeks after ProQuad (measles mumps rubella varicella vaccine live) .
Use with Other Vaccines
At least 1 month should elapse between a dose of a measles-containing vaccine such as M-M-R II, and a dose of ProQuad (measles mumps rubella varicella vaccine live) . If for any reason a second dose of varicella-containing vaccine is required, at least 3 months should elapse between administration of the 2 doses.
ProQuad (measles mumps rubella varicella vaccine live) may be administered concomitantly with Haemophilus influenzae type b conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine.
There are no data regarding the administration of ProQuad (measles mumps rubella varicella vaccine live) with inactivated poliovirus vaccine or pneumococcal conjugate vaccine.
Children under treatment for tuberculosis have not experienced exacerbation of the disease when vaccinated with live measles virus vaccine; no studies have been reported to date of the effect of measles virus vaccines on children with untreated tuberculosis.
16. Peltola H, et al. The elimination of indigenous measles, mumps, and rubella from Finland by a 12-year, two-dose vaccination program. NEngl J Med. 331(21):1397-1402, 1994.
17. Guess HA, et al. Population-based studies of varicella complications. Pediatrics. 78(4 Pt 2):723-727, 1986.
Last reviewed on RxList: 2/14/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Proquad Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.