Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Rotator cuff syndrome, Synovectomy, Synovitis, Tendon disorder, Tendon injury
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, 2011-02687, 2011-02688, 2011-02690, and 2011-02691. The 3 patients who received products from unknown manufacturers are unidentified; information for those 3 patients is captures 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 52-year-old female received a left arm injection of FLUZONE (lot number   [Due to memory limitations, the remainder of this text could not be compared.]  umber U1864AA) on an unspecified date. Immediately following vaccination, she complained of persistent left upper arm and shoulder pain, and a warm feeling in the shoulder area; tenderness at the AC joint; and painful limited range of motion. An x-ray of the shoulder 2 weeks post-vaccination revealed mild AC arthropathy, but was otherwise normal. An MRI one week later showed fluid in the soft tissues of the shoulder and subdeltoid bursa "possibly representing an inflammatory process" per radiology. Her treating physician diagnosed the patient with synovitis and subacromial bursitis. Six weeks post-vaccination, the patient underwent arthroscopic left glenohumeral synovectomy and debridement. Pain initially subsided, but recurred following physical therapy. An MRI performed 11 weeks post-vaccination showed partial tear of the distal supraspinatus tendon, tendonopathy, and fluid in the subacromial bursa and glenohumeral joint. She received intra-articular hydrocortisone/lidocaine. An MRI 5 months post-vaccination showed decreased fluid with otherwise unchanged findings. She continued to have painful active and passive range of motion of the shoulder. Arthroscopic surgery was performed 3 weeks after the second MRI to repair the rotator cuff tendon and arthrosis, and required hospitalization for the surgery. She had moderate improvement as of 9.5 months post-vaccination; status was unknown beyond that time. Documents held by sender: None.