Age: 55.0
Sex: F
Vaccine: FLUX, TDAP, FLUX, TDAP
Symptoms: Injection site injury, Injection site pain, Joint injury, Muscle oedema, Musculoskeletal pain
Clinical narrative: Case number PHHY2015US067809, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 572822) website on 27 May 2015. This report refers to a 55 year old female patient. She had no history of shoulder pain, fever, redness, soft tissue swelling, interval trauma, excessive lifting, pulling or exercising. Her vaccination history included administration of influenza vaccine (manufacturer and batch number: not reported) and TDAP (other manufacturer, batch number: not reported). On an unspecified date, she was vaccinated with influenza vaccine (manufacturer and batch number: not reported) and TDAP (batch number: not reported). On an unspecified date (less than 24 hours after vaccinations), she experienced left shoulder pain (dull pain) at rest, which was rated as 5 out of 10 in pain scale. The shoulder pain exacerbated during abduction. She also reported persistent dull pain at rest (3-4/10), sleep disturbances due to pain, difficulty lifting, carrying and driving. Physical examination confirmed left deltoid tenderness, restricted abduction, tenderness upon passive abduction and arm elevation. Though, reflexes, strength and sensation were intact, her serum C-reactive protein was normal. Non-enhanced magnetic resonance imaging of the left shoulder demonstrated abnormal osseous oedema in the lateral humeral head and neck and abnormal soft tissue oedema in the teres minor muscle (including its myotendinous junction and humeral insertion). She was given a subacromial corticosteroid injection which did not help. Her pain persisted but at approximately 6 weeks after vaccination, the pain with sleep reduced (4/10 to 2/10). Approximately 7 weeks after vaccination, her pain at rest reduced from 5/10 to 3/10. But she had persistent mild restricted motion on physical exam. After three months, non-enhanced MRI demonstrated ongoing inflammatory disease as evidence by new visualization of 8 mm humeral head cortical erosion. On an unspecified day, she was diagnosed with shoulder injury related to vaccine administration (SIRVA). On a further MRI, the humeral greater tuberosity erosion was depicted which was not only sequel of prolonged immune response but it also strongly suggested direct needle impact. Differential diagnoses included focal septic arthritis, calcific tendinitis with intraosseous penetration, gout and seronegative spondyloarthropathy enthesopathy. She did not undergo surgery. The outcome of the events was condition improving (recovering). Events were reported as non-serious. Seriousness assessment of the events ongoing inflammatory disease and humeral head cortical erosion, abnormal osseous oedema in the lateral humeral head and neck , and shoulder injury was upgraded (medically significant) based on the information available in the source document. Reporter stated that the post injection findings were attributed to sequel from direct needle impact and reactive change related to the injected material. Her prolonged response was likely due to antibody existing within her synovial tissue from prior vaccinations.