Epidemiologic Evidence

The committee reviewed one study to evaluate the risk of deltoid bursitis after the injection of a vaccine. This one controlled study (Black et al., 2004) contributed to the weight of epidemiologic evidence and is described below.

Black et al. (2004) conducted a retrospective cohort study in patients (2 years of age or older) enrolled in the Northern California Kaiser Permanente Medical Care Program. The study investigated the occurrence of bursitis/synovitis/tenosynovitis (reported as outpatient clinic visits, emergency room visits, and hospitalizations) after receipt of hepatitis A vaccine from April 1997 through December 1998. A total of 49,932 doses of vaccine were administered to 14,898 children (2–17 years) and 35,034 adults (> 18 years) during the study. The risk period for outpatient clinic visits and emergency room visits was defined as 30 days after vaccination, whereas the risk period for hospitalizations was defined as 60 days after vaccination. Two control periods were used to evaluate the risk prior to vaccine administration (31–60 or 31–90 days before vaccination) and following vaccine administration (91–120 or 91–150 days after vaccination). The two age groups (children and adults) and events following a first dose and second dose of hepatitis A vaccine were evaluated separately. The authors only reported statistically significant associations in the article, and only one analysis was listed. The relative risk of an emergency room visit for bursitis/synovitis/tenosynovitis within 30 days of administration of a second dose of hepatitis A vaccine among patients aged > 18 years was 0.55 (95% CI, 0.32–0.92). The authors did not observe a consistent protective effect between the administration of hepatitis A vaccine (first or second dose) and bursitis/synovitis/tenosynovitis for either age group in the three defined settings.

Weight of Epidemiologic Evidence

The committee has limited confidence in the epidemiologic evidence, based on one study that lacked validity and precision, to assess an association between the injection of a vaccine and deltoid bursitis.

Mechanistic Evidence

The committee identified three publications and three Vaccine Adverse Event Reporting System (VAERS) reports describing the development of deltoid bursitis after administration of a vaccine by injection. Black and colleagues (2004) identified cases of bursitis/synovitis/tenosynovitis developing

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