Yellow fever vaccine Side Effects

Please note - some side effects for 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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Yellow fever vaccine - for the Consumer

Yellow Fever Vaccine

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 Yellow Fever Vaccine:

Fever; mild headache; muscle aches; pain, swelling, and hardness at the injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); swelling in the brain.

Side Effects by Body System

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.

Other

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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