"For parents, childhood vaccines are a source of reassurance -- protecting your child against disease naturally helps you sleep better at night -- but also anxiety about side effects and reactions.
With misinformation about vaccines and heal"...
Attenuvax Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Attenuvax in Detail - Patient Information: Side Effects
You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.
Becoming infected with measles is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- high fever;
- easy bruising or bleeding, unusual weakness;
- severe blistering, peeling, and red skin rash;
- seizure (convulsions);
- weakness, numbness or tingly feeling in your feet and spreading upward;
- problems with hearing or vision;
- problems with eye movement, speech, swallowing, or bladder and bowel functions;
- severe lower back pain; or
- slow heart rate, trouble breathing, feeling like you might pass out.
Less serious side effects include:
- redness, burning, stinging, swelling, blistering, or hives where the shot was given;
- headache, dizziness;
- feeling irritable;
- fussiness, excessive crying;
- low fever, cough, runny nose;
- joint or muscle pain; or
- nausea, vomiting, diarrhea.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.
Read the entire detailed patient monograph for Attenuvax (Measles Virus Vaccine Live) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Attenuvax FDA Prescribing Information: Side Effects
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 polyvalent vaccine containing measles:
Body as a Whole
Hemic and Lymphatic 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.
Encephalitis; encephalopathy; measles inclusion body encephalitis (MIBE) (see CONTRAINDICATIONS); subacute sclerosing panencephalitis (SSPE); Guillain-Barré syndrome (GBS); febrile convulsions; afebrile convulsions or seizures; ataxia; ocular palsies.
Experience from more than 80 million doses of all live measles vaccines given in the U.S. through 1975 indicates that significant central nervous system reactions such as encephalitis and encephalopathy, occurring within 30 days after vaccination, have been temporally associated with measles vaccine very rarely.28 In no case has it been shown that reactions were actually caused by vaccine. The Centers for Disease Control and Prevention has pointed out that “a certain number of cases of encephalitis may be expected to occur in a large childhood population in a defined period of time even when no vaccines are administered”.29 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 natural measles (one per two thousand reported cases).30
Post-marketing surveillance of the more than 200 million doses of M-M-R and M-M-R II that have been distributed worldwide over 25 years (1971-1996) indicates that serious adverse events such as encephalitis and encephalopathy continue to be rarely reported.10
There have been reports of subacute sclerosing panencephalitis (SSPE) in children who did not have a history of natural 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 nationwide measles vaccine distribution, 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 natural measles, 6-22 cases of SSPE per million cases of measles. The results of a retrospective case-controlled study conducted by the Centers for Disease Control and Prevention suggest that the overall effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent higher risk of SSPE.31
Local reactions including burning/stinging at injection site; wheal and flare; redness (erythema); swelling; vesiculation at injection site.
Special Senses - Ear
Special Senses - Eye
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. No deaths or permanent sequelae were 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 1982-1993.32
Under the National Childhood Vaccine Injury Act of 1986, health care providers and manufacturers are required to record and report certain suspected adverse events occurring within specific time periods after vaccination. However, the U.S. Department of Health and Human Services (DHHS) has established a Vaccine Adverse Event Reporting System (VAERS) which will accept all reports of suspected events.28 A VAERS report form as well as information regarding reporting requirements can be obtained by calling VAERS 1-800-822-7967.
Read the entire FDA prescribing information for Attenuvax (Measles Virus Vaccine Live) »
Additional Attenuvax 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.
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