Frequency of adverse reactions to hepatitis B vaccine in 43,618 persons.
OBJECTIVE
To determine the incidence of adverse reactions to hepatitis B plasma-derived vaccine.


METHODS
Alaska natives (43,618) who received 101,360 doses of hepatitis B vaccine.


METHODS
All adverse reactions, excluding transient fever, myalgia, or soreness lasting less than 3 days, were reported. An intradermal skin test was developed to test purported adverse reactions. Records of the entire population were reviewed for Guillain-Barré syndrome (GBS).


METHODS
A statewide hepatitis B control program for Alaska natives.


RESULTS
Possible adverse reactions occurred in 39 persons. The most frequent adverse reactions were myalgia/arthralgia lasting longer than 3 days (14), followed by skin rashes (eight) and dizziness (seven). Skin tests were performed on 13 persons and were positive in five. Six of the persons with negative skin tests and eight persons who did not undergo skin testing received additional doses of vaccine without any adverse reactions. No increased incidence of GBS was found in the vaccinees.


CONCLUSIONS
Hepatitis B vaccine is safe and most adverse reactions are coincidental.
McMahon
B J
BJ
Department of Medicine, Alaska Native Medical Center, Anchorage 99510-7741.
Helminiak
C
C
Wainwright
R B
RB
Bulkow
L
L
Trimble
B A
BA
Wainwright
K
K
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000413:Alaska / Q000453:epidemiology; D004244:Dizziness / Q000139:chemically induced / Q000175:diagnosis / Q000453:epidemiology; D003875:Drug Eruptions / Q000175:diagnosis / Q000453:epidemiology* / Q000209:etiology; D006509:Hepatitis B / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D007198:Indians, North American; D007428:Intradermal Tests; D009140:Musculoskeletal Diseases / Q000139:chemically induced / Q000175:diagnosis / Q000453:epidemiology*; D010146:Pain / Q000139:chemically induced / Q000175:diagnosis / Q000453:epidemiology*; D011129:Polyradiculoneuropathy / Q000139:chemically induced / Q000175:diagnosis / Q000453:epidemiology; D014761:Viral Hepatitis Vaccines / Q000009:adverse effects*
D014761:Viral Hepatitis Vaccines