ProQuad Side Effects

Please note - some side effects for ProQuad may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of ProQuad - for the Consumer

ProQuad

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using ProQuad:

Diarrhea; dizziness; fever; general unwell feeling; headache; irritability; mild rash; muscle or joint ache or pain; nausea; pain, tenderness, soreness, or swelling at the injection site; tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; loss of coordination; mental or mood changes; numbness or tingling in the fingers or toes; red, swollen, blistered, or peeling skin; seizures; unusual bruising or bleeding; vision or hearing changes.

ProQuad Side Effects - for the Professional

ProQuad

Children 12 to 23 Months of Age

ProQuad was administered to 4497 children 12 to 23 months of age in clinical trials without concomitant administration with other vaccines. The safety of ProQuad was compared with the safety of M-M-R II and VARIVAX given concomitantly at separate injection sites. The safety profile for ProQuad 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 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 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 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.

The following additional vaccine-related clinical adverse experiences (incidence ≥0.2% but <1%) were observed in individuals following a single dose of ProQuad. Solicited adverse experiences are designated with the symbol (‡).

Infections and infestations: otitis, otitis media, pharyngitis, viral infection.

Metabolism and nutrition disorders: anorexia.

Psychiatric disorders: crying, insomnia, sleep disorder.

Nervous system disorders: somnolence.

Respiratory, thoracic, and mediastinal disorders: cough, nasal congestion, respiratory congestion, rhinorrhea.

Gastrointestinal disorders: vomiting.

Skin and subcutaneous tissue disorders: miliaria rubra, rubella-like rash‡.

General disorders and administration site conditions: malaise.

Post-marketing reports

The following additional adverse events have been reported with ProQuad in post-marketing experience.

Infections and infestations: herpes zoster, varicella.

Immune system disorders: anaphylactic reaction.

Nervous system disorders: ataxia, convulsion, encephalitis, febrile seizure.

Skin and subcutaneous tissue disorders: pruritus.

Adverse Experiences after vaccination with M-M-R II 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

Atypical measles, candidiasis, cellulitis, infection, influenza, measles, orchitis, parotitis, respiratory infection, skin infection.

Blood and the lymphatic system disorders

Lymphadenitis, regional lymphadenopathy, thrombocytopenia.

Immune system disorders

Anaphylactoid reaction, anaphylaxis and related phenomena such as angioneurotic edema, facial edema, and peripheral edema, anaphylaxis in individuals with or without an allergic history.

Psychiatric disorders

Agitation, apathy, nervousness.

Nervous system disorders

Afebrile convulsions or seizures, aseptic meningitis, Bell’s palsy, cerebrovascular accident, dizziness, dream abnormality, encephalopathy, Guillain-Barré syndrome, headache, hypersomnia, measles inclusion body encephalitis, ocular palsies, paraesthesia, polyneuritis, polyneuropathy, subacute sclerosing panencephalitis, syncope, transverse myelitis, tremor.

Eye disorders

Edema of the eyelid, irritation, optic neuritis, retinitis, retrobulbar neuritis.

Ear and labyrinth disorders

Ear pain, nerve deafness.

Vascular disorders

Extravasation.

Respiratory, thoracic and mediastinal disorders

Bronchial spasm, bronchitis, epistaxis, pneumonitis, pneumonia, pulmonary congestion, rhinitis, sinusitis, sneezing, sore throat, wheezing.

Gastrointestinal disorders

Abdominal pain, flatulence, hematochezia, mouth ulcer.

Skin and subcutaneous tissue disorders

Erythema multiforme, Henoch-Schönlein purpura, herpes simplex, impetigo, panniculitis, purpura, skin induration, Stevens-Johnson syndrome, sunburn.

Musculoskeletal, connective tissue and bone disorders

Arthritis and/or arthralgia (usually transient and rarely chronic [see below]), musculoskeletal pain, myalgia, pain of the hip, leg, or neck, swelling.

Reproductive system and breast disorders

Epididymitis.

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.

Post-marketing surveillance

The discussion that follows describes adverse reactions which have been identified post-approval for either the monovalent components of ProQuad or ProQuad. 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.

Febrile seizures have been reported in children receiving ProQuad. Consistent with clinical study data on the timing of fever and measles-like rash, an interim analysis of a post marketing observational study in children (N=14,263) receiving their first dose of vaccine has shown that febrile seizures occurred more frequently 5-12 days following vaccination with ProQuad (0.5 per 1000) when compared with data from children in a historical, age- and gender-matched, control group vaccinated with M-M-R II and VARIVAX (N=14,263) concomitantly (0.2 per 1000). In the 0-30 day time period following vaccination, the incidence of febrile seizures with ProQuad (1.0 per 1000) was not greater than that observed in children receiving M-M-R II and VARIVAX concomitantly (1.3 per 1000).

Side Effects by Body System

Dermatologic

Dermatologic side effects have included miliaria rubra, rubella-like rash, measles-like rash, varicella-like rash, Henoch-Schonlein purpura, herpes simplex, impetigo, panniculitis, pruritus, purpura, skin induration, Stevens-Johnson Syndrome, erythema multiforme, urticaria, and rash.

Local

Local side effects have included pain, tenderness, soreness, erythema, ecchymosis and rash.

General

General side effects have included fever, irritability and malaise.

Psychiatric

Psychiatric side effects have included crying, insomnia, sleep disorder, agitation, apathy and nervousness.

Respiratory

Respiratory side effects have included upper respiratory infection, cough, nasal congestion, respiratory congestion, rhinorrhea, bronchial spasm, bronchitis, epistaxis, pneumonitis, pneumonia, pulmonary congestion, rhinitis, sinusitis, sneezing, sore throat, and wheezing.

Nervous system

Nervous system side effects have included somnolence, afebrile convulsions, seizures, aseptic meningitis, Bells' palsy, cerebrovascular accident, dizziness, dream abnormality, encephalitis, encephalopathy, Guillain-Barre syndrome, headache, hypersomnia, measles inclusion body encephalitis, paresthesia, polyneuritis, polyneuropathy, subacute sclerosing panencephalitis, syncope, transverse myelitis and tremor. Postmarketing reports have included ataxia, convulsion, and febrile seizure.

Gastrointestinal

Gastrointestinal side effects have included diarrhea, vomiting, abdominal pain, flatulence, hematochezia, anorexia, and mouth ulcer.

Ocular

Ocular side effects shave included edema of the eyelid, irritation, optic neuritis, retinitis, and retrobulbar neuritis.

Cardiovascular

Cardiovascular side effects have included extravasation.

Other

Other side effects have included ear pain, nerve deafness, otitis, otitis media, pharyngitis, and viral infection.

Musculoskeletal

Musculoskeletal side effects have included arthritis, arthralgia, musculoskeletal pain, myalgia, swelling, and pain of the hip, leg or neck.

Immunologic

Immunologic side effects have included anaphylactoid reaction, anaphylaxis, angioneurotic edema, facial edema, and peripheral edema.

Other

Other side effects have included lymphadenitis and regional lymphadenopathy.

Hematologic

Hematologic side effects have included thrombocytopenia.

Other

Other side effects have included atypical measles, candidiasis, herpes zoster, influenza, measles, orchitis, parotitis, respiratory infection, and skin infection.

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