Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Bone marrow oedema, Bursitis, Drug administered at inappropriate site, Immediate post-injection reaction, Inflammation
Clinical narrative: Initial report received from a healthcare professional from the Department of Health and Human Services, Division of Vaccine Injury Compensation, on 09 May 2011. It pertains to 1 of 6 patients, described by the reporter in a literature article, who experienced adverse events following vaccination. The article describes 13 patients; 6 were identified as having received sanofi pasteur products, 4 received products from other manufacturers, and 3 received products from unknown manufacturers. The events for the other 5 patients who received sanofi pasteur products are captured in case numbers 2011-02686, 2011-02687, 2011-02688, 2011-02689, and 2011-02691. The 3 patients who received products from unknown manufacturer are unidentified; information for those 3 patients is captured in 2011-00466. Abstract: "Shoulder pain is a common transient side-effect of vaccination. Infrequently, patients can develop prolonged shoulder pain and dysfunction following vaccination. A series of 13 cases are described in which persistent shoulder dysfunction and pain developed following immunization. Common clinical characteristics include absence of a history of prior shoulder dysfunction, previous exposure to vaccine administered, rapid onset of pain, and limited range of motion. The proposed mechanism of injury is the unintentional injection of antigenic material into synovial tissues resulting in an immune-mediated inflammatory reaction. Careful consideration should be given to appropriate injection technique when administering intramuscular vaccinations to reduce the risk of shoulder injury." All individuals in the case series were adults, and 85% were women. With exception, all received other influenza vaccine or a tetanus-containing vaccine prior to onset of symptoms. Mean body mass index (BMI) was 27.2 (range 19.4 - 41/3). Shoulder pain was present in all patients, with onset occurring less than 24 hours after vaccination in 93% and immediately following injection in 54%; in addition, 46% reported concerns regarding vaccine administration, specifically that the vaccine had been administered "too high" in the deltoid. The most common findings were limited and painful range of motion. None of the 39% of patients who underwent electrodiagnostic studies had findings suggestive of a neurological disorder. MRI findings included fluid collections in the deep deltoid or overlying the rotator cuff tendons, bursitis, fluid "greater than typically seen" within the bursa, tendonitis, rotator cuff tears, and (in one patient) subchondral changes in the humerus with overlying severe tendonitis and fluid accumulation. Severity and duration of shoulder dysfunction varies, with more than half requiring at least one injection of a corticosteroid. Surgical intervention was performed in 31%, with half of those requiring an second surgical intervention. All patients had symptoms for last least 6 months, with some cases persisting for many years. A 29-year-old female received an injection of DIPHTHERIA AND TETANUS TOXOIDS, DIPHTHERIA , TETANUS AND ACELLULAR PERTUSSIS VACCINE, or INFLUENZA VACCINE (name of vaccine and lot number(s) not reported; noted to be a sanofi pasteur vaccine) on an unspecified date. The patient reported that the vaccine was given "up high" in the left deltoid, and that the injection "hit something hard" and was associated with intense pain. Immediately following vaccination, she complained of activities of daily living (ADL's) and range of motion being very painful. Examination showed severely limited painful range of motion and impingement. She was treated with oral steroids. Six weeks post-vaccination, an MRI showed extensive increased signal involving the supraspinatus tendon possibly representing severe tendonitis or tear as well as subchondral changes in the area of the greater tubersosity of the humerus with subchondral cysts and bone marrow edema. She received steroid injections into the shoulder joint over the next 8 weeks, with temporary relief. At 8.5 months post-vaccination, she underwent open surgery of the shoulder. The operative report documented "substantial abnormality of the humeral head" near the insertion point of the posterior supraspinatus and anterior infraspinatus tendons, as well as the area 2cm medially to this. Surgeons replicated the reported path of injection during surgery with the needle passing directly to the area of damaged bone. The bone "caved" to a depth of 1cm with pressure from the needle. This portion of bone was not considered viable, and was removed. The deltoid bursa was "quite thickened, inflamed, and scarred" and was not removed. Thickened tissue around tendons was removed. Tendons were repaired. Biopsy of the tendon showed inflamed fibromuscular tissue. Bone biopsy identified osseous and cartilaginous tissue with no abnormalities documented. There was some improvement but she developed frozen shoulder 3.5 months following surgery and underwent manipulation under anesthesia to lyse scarring. She had persistent pain, and an MR arthrogram 1.5 years post vaccination showed a thin rotator cuff tendon with no tear. She underwent additional surgery to lyse adhesions to the shoulder, and required extensive physical therapy. Hospitalization was required for the surgery. Almost 6 years post-vaccination, the patient had limited range of motion in the shoulder, mild rotator cuff weakness, inability to lift her arm over her head, global pain in the shoulder, and required modification in performing ADL's. Documents held by sender: None.