Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Reflex test normal, Spinal X-ray abnormal, X-ray normal
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 2011-02687, 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 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   [Due to memory limitations, the remainder of this text could not be compared.]  9-year-old female received a left arm injection of FLUZONE SV '2005-'2006 on an unspecified date (lot reported as V1839AA, not a valid lot number; U1839AA is a valid sanofi pasteur lot number). Immediately following vaccination, she reported pain in the shoulder, arm, and hand: limitation of range of motion of the shoulder due to pain; and transient subjective numbness and tingling. Weakness was not reported, or found on exam. Per the patient, "it felt to her that the needle hit her bone" during vaccination and that the vaccine was administered "too high". An x-ray of the shoulder 17 days post-vaccination was normal, and an x-ray of the cervical spine 1 week later showed C5-6 mild disk space narrowing. An EMG/NCS (electromyogram/nerve conduction study) performed 38 days post-vaccination was normal and included antidromic sensory response testing. Extension of the previous EMG/NCS was conducted several weeks later and was also normal. Approximately 2.5 months post-vaccination, autonomic testing was also normal, including autonomic reflex screen, valsalva, deep breathing, head-up tilt, and QSART testing. She was treated with anti-inflammatories and narcotics as well as physical therapy. There were no associated hospitalizations or surgical procedures. The pain resolved at 7.5 months following vaccination with no residual deficits. Per the reporter, no additional information was available. Documents held by sender: None.