Hepatitis B vaccines - musculoskeletal reactions----Australian adverse drug
Vol. 15, no. 2 (May 1996)
ADRAC supports the immunisation program which includes the appropriate use of hepatitis B
vaccine and it has been estimated that about two million doses of the vaccine are given
annually.# However, it is important for prescribers to be aware that adverse effects can
occasionally occur and from 1988 to March 1996, ADRAC has received 597 reports of
suspected adverse reactions in association with recombinant hepatitis B vaccine and the
reactions reported most commonly are listed in Table 2. In many cases, symptoms mentioned
in the table occurred in combination resembling a 'flu like illness'. Most reports of this
type described an intense but short-lived illness which usually responded to rest and
Of interest are the 106 reports (F:M=62:40, age range: 3 to 69 (median 39) years) of
musculoskeletal symptoms such as arthritis, arthralgia, and/or myalgia which were not
related to the injection site. About half of these cases were part of a flu-like illness
and the vaccine was the only suspected causal agent in the majority of them. Of those
reports which provided the information, all documented onset of the reaction within the
first month with the majority (70%) commencing within the first week after vaccination.
Where it was specified, symptoms of this type were reported following first (32 reports),
second (40), third (15), and fourth (2) injections. Half of the reports describing
reactions after the second injection also documented similar,
but less severe, symptoms following the first injection. Reactions recurring on
rechallenge tended to be more rapid in onset.
The majority of patients had joint symptoms. In 21 patients these were accompanied by
myalgia whereas myalgia alone was experienced in a further 29 patients. The pattern of
joint involvement varied greatly including arthralgia in the hands, wrists, elbows,
shoulders, neck, knees and/or ankles. A minority of reports described both upper and lower
limb involvement. Full recovery was documented in more than half the cases and in those
reports which provided the information, the majority (70%) recovered within a month of
Health professionals should be aware that prophylaxis with recombinant hepatitis B
vaccines may be associated with joint and/or muscle pains generally commencing in the
first month after vaccination and lasting for several weeks.
Most Common Reactions to Hepatitis B Vaccines
Number of reports
Rash and/or itch
Anorexia, nausea or vomiting
Fever and/or rigors
Injection site reactions
Dizziness and/or vertigo
*Commonly more than one reaction term was included in each report.
#Reference details available on request.