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SAFETY OF HAEMOPHILUS INFLUENZAE TYPE b VACCINE.

In 1985, the Haemophilus influenzae type b vaccine was licensed for children two to five years of age; more than 4.5 million doses were sold in the first year of marketing. Milstien and colleagues compiled and analyzed the records of adverse reactions to the vaccine reported to the FDA during the first year the vaccine was marketed.

Of 152 reported reactions, 12 percent met the criteria for a serious reaction; these events included 13 seizures and two anaphylactoid reactions. The reports included 43 cases of skin reactions, 16 cases of vomiting, 10 cases resembling serum sickness, and one case each of hemolytic- uremic syndrome, nephrotic syndrome, cerebrovascular accident, and death.

Despite the limitations of the FDA's spontaneous- reporting system (which include underreporting), the data suggest that most adverse reactions attributed to the vaccine were benign and that the vaccine is safe. Health- care providers should note that the above reactions are not listed in the information provided with the vaccine and that adverse reactions should be reported to the FDA.

— PMM

Published in Journal Watch General Medicine August 28, 1987

Citation(s):

Milstien J B; Gross T P; Kuritsky J N. Adverse reactions reported following receipt of Haemophilus influenzae type b vaccine: an analysis after 1 year of marketing. Pediatrics 1987 Aug 80 270-274.

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