Age: 55.0
Sex: F
Vaccine: FLUX, TDAP, FLUX, TDAP
Symptoms: Sleep disorder
Clinical narrative: Case number PHHY2015US100851 is an initial spontaneous report via vaccine adverse event reporting system (the source of the case in VAERS is a literature publication, VAERS reference number: 580004) received on 11 Aug 2015. This report refers to a 55 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and Tdap vaccine (other manufacturer, batch number: not reported) on unknown dates. She was presented with a three month history of left shoulder pain which occurred less than 24 hours after receiving vaccines. She described her pain as dull/achy, 5 out of 10 (10 point scale with 10 being the worst pain) at rest and exacerbating with shoulder manipulation, most notably with abduction. In addition, she reported persistent 3-4/10 dull pain at rest, sleep disturbances due to pain, mild restricted motion and difficulty with lifting, carrying and driving. The patient denied prior shoulder pain, fever, redness, soft tissue swelling, interval trauma, excessive lifting, pulling or exercising. Physical examination findings were positive for left deltoid tenderness, restricted adduction and tenderness upon passive abduction. Her arm elevation reflexes, strength and sensation were intact. Serum C-reactive protein was normal. After minimal avail from multiple sessions of physical therapy and oral pain medications, a non-enhanced magnetic resonance imaging (MRI) of the left shoulder was ordered and the findings were as follows: initial non-enhanced MRI of the left shoulder demonstrated abnormal osseous edema in the lateral humeral head and neck, and abnormal soft tissue edema in the teres minor muscle including its myotendinous junction and humeral insertion. These post-injection findings were attributed to sequela from direct needle impact and reactive change related to the injected material. A 3-month follow-up (after an ineffective subacromial corticosteroid injection) non enhanced MRI demonstrated ongoing inflammatory disease as evidenced by new visualization of an 8-mm humeral head cortical erosion. The patient's pain persisted, but at approximately 6 weeks post-injection, her pain with sleep reduced from 4/10 to 2/10. In addition, her rest pain reduced from 5/10 to 3/10 at approximately 7 weeks, but with persistent mild restricted motion on physical examination. No information about prior exposure to vaccine was provided. She was diagnosed with shoulder injury related to vaccine administration (SIRVA). Less likely differential considerations included focal septic arthritis, calcific tendinitis with intraosseous penetration, gout and seronegative spondylorathropathic enthesopathy. The final outcome of events was reported as condition unchanged. The events were reported as non-serious, but the event SIRVA was upgraded as medically significant based on the information available in the source documents. The causality of the event was not reported. The reporter stated that prolonged shoulder pain occurring acutely after vaccination should prompt physicians to incorporate SIRVA in their differential of possible causes. In addition, vaccine administrators in health care facilities nationwide should be educated on the potential risks (physician and economic) of over-penetration associated with the current CDC's needle length recommendations.