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, 2011-02687, 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 29-year-old male received a left arm injection of FLUZONE (lot number   [Due to memory limitations, the remainder of this text could not be compared.]  er U1553AA) on an unspecified date. Immediately following vaccination, he complained of tenderness of the subdeltoid bursa and painful limited range of motion of the shoulder. He reported that the vaccine administrator "had to push pretty hard to get the shot in the arm" and that the injection was given "too superiorly". The initial diagnosis 20 days post-vaccination was subacromial bursitis and rotator cuff tendonitis. At 42 days post-vaccination, the patient received an injection of steroid into the subdeltoid bursa and physical therapy. Shoulder improved to near-normal, however a second cortisone injection was required 15 weeks post-vaccination when symptoms returned. Symptoms of impingement and persistent painful limited range of motion returned following the second steroid injection. The patient underwent surgery at 5.5 months post-vaccination with acromioplasty and bursectomy. The operative report noted thickened bursal tissue throughout as well as scar tissue within the subacromial space. There was significant improvement in range of motion and pain following surgery. However, he complained of reduced range of motion and recurrent pain 2 months post-surgery, which was felt to be due to "overzealous scar tissue reaction to the surgery". The patient was treated with a third cortisone injection, and the patient continued with physical therapy. He required hospitalization for the surgical procedure. The patient continued to have mild limited range of motion 9 months post-vaccination; no further information was available. Documents held by sender: None.