Sex: U
Vaccine: FLUX, TD, TDAP
Symptoms: Unevaluable event
Clinical narrative: Initial report was received from another manufacturer (reference number S2011US00115) who provided a copy of a scientific literature article on 21 January 2011. A group of 13 patients (11 female and 2 male) with an age range between 26-83 years of age and a Body Mass Index (BMI) range between 19.4-41.3, received an injection (route and site not reported) of DIPHTHERIA AND TETANUS TOXOIDS (2 patients), manufacturer and lot number not reported, DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, (2 patients), manufacturer and lot number not reported, and INFLUENZA VACCINE (8 patients), manufacturer and lot number not reported. "This report summarizes a series of cases in which persistent shoulder pain following vaccination was felt to be related to administration of the vaccine, proposes a mechanism by which such injuries may occur, identifies common historical and physical examination findings in patients with shoulder pain related to vaccine administration and offers considerations for reducing the risk of shoulder injury related to vaccine administration. Following the review, 13 potential cases submitted between 2006 and 2010 were identified for inclusion in this report. There were 11 confirmed (85%) and 2 unconfirmed (15%) patient with repeat or sequential 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. In the course of reviewing claims submitted from 2006 through 2010, the VICP identified 13 claims in which it appeared that vaccine administration led to significant shoulder pain and dysfunction. The demographic and clinical characteristics of these 13 case are shown in Table 1. All individuals in this case series were adults, 85% were women, and, with one exception, all received either influenza vaccine or tetanus-containing vaccine prior to the onset of symptoms. The mean body mass index (BMI) of patients in the case series was 27.2 (range 19.4-41/3). A history of prior immunization with the same vaccine was confirmed in 85% of the cases. Among patient in whom a history of previous vaccination was confirmed, the interval between vaccinations was no less than 10 years for those receiving tetanus-containing vaccines and no less than 11 months of influenza vaccine. Shoulder pain was present in all patients. Onset of pain was reported as occurring less than 24 hours after vaccination in 93%" (reported in table as 39%)" and occurred immediately following injection in 54% of our cases. Forty-six percent of the patients voiced concerns regarding vaccine administration, specifically that the vaccination had been administered "too high" in the deltoid. The most common findings on examination were limited and painful range of motion. Skin and local injection site reactions were not reported and sensory symptoms such as tingling and numbness in the affected extremity were uncommon. Weakness was not a common finding in any of the cases during the initial examination and when found was attributed to pain. Deep tendon reflexes, when tested, were noted to be normal. Among the 39% of patients who underwent electrodiagnostic studies, none had findings suggestive of a neurological disorder such as brachial neuritis. When performed, MRI findings varied but included fluid collections in the deep deltoid or overlying the rotator cuff tendons (39%), 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. A complete rotator cuff tear was found in 15% of cases and, in one case, associated atrophy of the rotator cuff tendon was noted. Sixty-three percent of the MRI's performed in our case series were conducted within three months of the date of symptom onset. Routine X-rays of the shoulder were performed less frequently and did not provide helpful diagnostic information among patients in this series. The severity and duration of shoulder dysfunction varied among patients in this case series. More than half of the patients required at least one injection of a corticosteroid over time. Surgical intervention was performed in 32% of cases with half of those cases requiring a second surgical intervention. Review of the available records showed that shoulder symptoms persisted among our cases from six month to may years. All patients had symptoms for at least six months. Less than one third of patients had complete recovery while the majority of patients in this series had continuing symptoms including persistent pain, limited range of motion, and pain on range of motion at last follow-up. Of the patients in our series, none had a history of symptomatic shoulder problems prior to vaccination. They all received a vaccine to which they had previously been exposed. They all experienced a rapid onset of shoulder pain (range: immediate to four days) following vaccination. They all developed shoulder symptoms limited to the vaccinated shoulder. They all had symptoms and physical findings consistent with a local immune-mediated inflammatory musculoskeletal shoulder injury. One of our cases provided additional evidence to support vaccine administration as a causal element in this type of injury. In this case surgeons replicated the path of the vaccine administration by inserting a needle into the deltoid area at the location identified by the patient as the injection site during reparative arthroscopic shoulder surgery. The path of the needle led through an area containing an inflamed and scarred bursa and thickened tissue around a damaged tendon. Beneath the tendon the needle came into contact with abnormally friable bone on the greater tuberosity of the humerus that gave way with pressure from the needle. We believe it is likely that this patient as well as the other patients in our series developed shoulder pain and dysfunction through the mechanism proposed Bodor and demonstrated experimentally by Dumonde. We confirmed that almost all of our cases had received at least one dose of the same vaccine in the past. The two cases for which prior vaccination could not be confirmed by the medical records included one case of influenza vaccine administration and one case involving administration of a tetanus-containing vaccine." Follow-up information was received from the author of the article, from the Department of Health and Human Services, on 09 May 2011. Of the 13 patients described in the literature article, 10 had manufacturer information, and 6 of those 10 were reported as having received a sanofi pasteur vaccine. This case now pertains to only the three patients who experienced adverse events following vaccination with vaccines from an unknown manufacturer. Events for the 6 patients who received sanofi pasteur vaccines are captured in case numbers 2011-02686, 2011-02687, 2011-02688, 2011-02689, 2011-02690, and 2011-02691. The author noted there was no additional information to provide regarding these patients. Documents held by sender: None.