Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tendon injury, X-ray limb abnormal
Clinical narrative: Initial report received from a healthcare professional from the agency, 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, 2011-02688, 2011-02689, 2011-02690, and 2011-02691. The 3 patients who received products from unknown manufacturers 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 one exception, all received either INFLUENZA vaccine or a TETANUS-containing vaccine prior to the 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 varied, with more than half requiring at least one injection of a corticosteroid. Surgical intervention was performed in 31%, with half of those requiring a second surgical intervention. All patients had symptoms for at least 6 months, with some cases persisting for many years. A 75-year-old female received a left arm injection of FLUZONE (lot not   [Due to memory limitations, the remainder of this text could not be compared.]  not reported) on an unspecified date. Immediately following vaccination, she reported pain in the shoulder with limited range of motion due to discomfort and arm pain. At 84 days post-vaccination she was diagnosed with adhesive capsulitis. An MRI performed 4.5 months following vaccination showed tendinosis and undersurface tear of the distal 2cm of the supraspinatus tendon and degenerative changed of the AC joint. An x-ray performed 1 months later showed AC joint arthropathy. Additional diagnoses included impingement syndrome of the shoulder. She was treated with physical therapy, and did not require any hospitalizations or surgical procedures. She fully recovered 8.5 months following vaccination. Documents held by sender: None.