Hepatitis B vaccines - musculoskeletal reactions----Australian adverse drug reactions bulletin
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 analgesics.

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 onset.

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.

Table 2
Most Common Reactions to Hepatitis B Vaccines

Reaction*                        Number of reports
Rash and/or itch                         181
Anorexia, nausea or vomiting             131
Musculoskeletal pain                     106
Fever and/or rigors                       99
Headache                                  96
Injection site reactions                  89
Dizziness and/or vertigo                  64

*Commonly more than one reaction term was included in each report.
#Reference details available on request.