Yellow fever vaccine Side Effects

Some side effects of yellow fever vaccine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to yellow fever vaccine: subcutaneous powder for injection

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first vaccine.

Keep track of any and all side effects you have after receiving this vaccine (for up to 30 days after the shot). If you ever need to receive a booster dose, you will need to tell the doctor if the previous dose caused any side effects.

Becoming infected with yellow fever is much more dangerous to your health than receiving the vaccine to protect against it. 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 while taking yellow fever vaccine: pale skin, hives; weakness, dizziness, difficulty breathing, rapid heart rate; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects (may occur up to 30 days after you receive the vaccine):

• flu symptoms, stiff neck or back, vomiting, confusion, memory loss, irritability, loss of balance or coordination;

• weakness or prickly feeling in your fingers or toes, sensitivity to light;

• problems with walking, breathing, speech, swallowing, vision, or eye movement;

• severe lower back pain, loss of bladder or bowel control;

• muscle weakness or loss of movement in any part of your body; or

• behavior changes, seizure (black-out or convulsions).

Less serious side effects (may occur for 5 to 10 days after you receive the vaccine) include:

• low fever, mild headache, general ill feeling;

• mild rash, muscle pain, joint pain, body aches; or

• pain, tenderness, swelling, or a lump where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to yellow fever vaccine: subcutaneous powder for injection

Other

Minor side effects have included mild headache, myalgia, malaise, asthenia and low-grade fever for 5 to 10 days after vaccination in < 5% to 30% of vaccinees. The incidence of minor adverse events was lower in vaccinees > 60 years than in younger subjects.

Local

Local side effects have included edema, erythema, hypersensitivity, pain, or mass at the injection site.

Hypersensitivity

Hypersensitivity reactions have infrequently included immediate reactions characterized by rash, urticaria, and/or asthma. These mainly occur in vaccinees with histories of egg allergy.

Nervous system

Nervous system side effects have very rarely included neurotropic disease (YEL-AND, post-vaccinal encephalitis) which has been fatal in rare instances. Symptoms have included diaphoresis, rigors, fever, malaise, headache, confusion, expressive aphasia, arm numbness, loss of fine motor control, severe dysarthria, loss of consciousness, elevated WBCs and protein in CSF, and/or leukocytosis. Immunosuppression and age < 9 months are known risk factors. The estimated incidence for all ages is 5.3 cases per million vaccinees.

Fifteen cases of neurotropic disease were reported before 1960, 13 of these occurred in infants < 4 months and 2 in infants 6 and 7 months old. Six cases were reported worldwide between 1960 and 1996, 3 of these occurred in adults, and the other 3 in a 1-month-old infant, a 3-year-old, and a 13-year-old. A genetic variant of the vaccine virus was isolated from the brain of the 3-year-old, who died of encephalitis.

Four nonfatal cases of probable 17D vaccine-associated neurotropic disease were reported in the U.S. between 2001 and 2002. High levels of yellow fever-specific IgM antibody were observed in these patients' CSF; however viral isolation was negative or not performed.

Other

Seven cases of YEL-AVD were reported between 1996 and 2001, 4 of them in U.S. residents. All patients (ages 5 to 79 years old) were considered healthy and did not have immunodeficiency. Six of these patients died 8 to 11 days after vaccination (1 had been vaccinated with the 17D-204 strain and 2 with the 17DD strain). A liver biopsy revealed rare yellow fever virus antigen within Kupffer cells. In 3 of the fatal cases, hepatic midzonal necrosis, microvesicular fatty change, and Councilman bodies were observed, which are characteristic of wild-type yellow fever. Vaccine-type yellow fever virus was isolated from blood and autopsy material.

Vaccine-associated viscerotropic disease (YEL-AVD, multiple organ system failure), which may be fatal, has been reported rarely. It is characterized by initial symptoms of a nonspecific febrile syndrome with fatigue, myalgia, and headache. It quickly progresses to severe illness including respiratory failure, elevated hepatocellular enzymes, lymphocytopenia, thrombocytopenia, hyperbilirubinemia, hypotension with poor tissue perfusion, and/or renal failure requiring hemodialysis. Causality has not been clearly established. The syndrome may be related to unknown host factors rather than virulence of the 17D yellow fever strain. Recent reports suggest that a history of thymic dysfunction (e.g., myasthenia gravis, thymoma, thymectomy, DiGeorge syndrome) and age > 60 years may be risk factors for developing YEL-AVD. The estimated incidence is 1 per 400,000 doses.

Health care providers should report any allergic or unusual adverse reactions to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 (USA) and the manufacturer.

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