Thrombocytopenia (Page 4)
Individuals with current thrombocytopenia may develop more severe thrombocytopenia following vaccination.
In addition, individuals who experienced thrombocytopenia with the first dose of M-M-RII (or its component vaccines)
may develop thrombocytopenia with repeat doses. Serologic status may be evaluated to determine whether or not additional doses of vaccine are needed. The potential risk to benefit ratio should be carefully evaluated before considering vaccination
in such cases
(see ADVERSE REACTIONS).
ADVERSE REACTIONS
The following adverse reactions are listed in decreasing order of severity, without regard to causality,
within each body system category and have been reported during clinical trials, with use of the marketed
vaccine, or with use of monovalent or bivalent vaccine containing measles, mumps, or rubella:
Body as a Whole
Panniculitis; atypical measles; fever; syncope; headache; dizziness; malaise; irritability
.Cardiovascular System
Vasculitis.
Digestive System
Pancreatitis; diarrhea; vomiting; parotitis; nausea.
Endocrine System
Diabetes mellitus.
Hemic and Lymphatic System
Thrombocytopenia (see WARNINGS, Thrombocytopenia); purpura; regional lymphadenopathy;
leukocytosis.
Immune System
Anaphylaxis and anaphylactoid reactions have been reported as well as related phenomena such as angioneurotic
edema (including peripheral or facial edema) and bronchial spasm in individuals with or without an allergic history
Musculoskeletal System
Arthritis; arthralgia; myalgia.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 sex, being greatest in adult females
and least in prepubertal children. This type of involvement as well as myalgia and paresthesia, have also been reported following administration of MERUVAXII
.
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.
Following vaccination in children, reactions in joints are uncommon and generally of brief duration. In women, incidence
rates for arthritis and arthralgia are generally higher than those seen in children (children: 0-3%; women: 12-26%),{17,56,57} 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 in adult women. Even in women older than 35 years, these reactions are generally well tolerated and rarely interfere
with normal activities.
Nervous System
Encephalitis; encephalopathy; measles inclusion body encephalitis (MIBE) (see CONTRAINDICATIONS); subacute
sclerosing panencephalitis (SSPE); Guillain-Barré Syndrome (GBS); acute disseminated encephalomyelitis (ADEM);
transverse myelitis; febrile convulsions; afebrile convulsions or seizures; ataxia; polyneuritis; polyneuropathy
; ocular palsies; paresthesia.
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