Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Product administered at inappropriate site, X-ray limb normal
Clinical narrative: Bilateral adhesive capsulitis of shoulder; Received an influenza vaccine high up on the shoulder; This is a spontaneous literature case, initially received on 20-Jul-2020 concerning a 64-year-old male patient.  The patients' medical history and concomitant medication were not reported.  On unspecified dates, the patient was administered INN Flu vaccine seasonal [influenza virus vaccine polyvalent; anatomical location: left arm, high up on the shoulder, dose, route od administration, batch number and expiry date: not reported] (explicitly coded as 'Vaccine administered at inappropriate site') for an unknown indication.  On unspecified dates, few days after the vaccination, the patient woke up one morning with mild left shoulder soreness. He developed a similar soreness in the right shoulder a couple days later. The patient reported that he experienced pain in both shoulders with active range of motion. Specifically, he experienced pain in the right lateral posterior deltoid with reaching behind his back and shoulder abduction with his right arm. He also reported pain in the left anterior deltoid while reaching behind his back and across his body with his left arm. He described the pain as sharp and brief, approaching an 8 on a 1-10 scale. The patient denied any numbness in either upper extremity and any particular exertion or exercise in the days prior to the onset of pain. Physical examination of the right shoulder showed a range of motion of 115° flexion, 40° extension, 60° abduction, 90° internal rotation, and 40° external rotation. Left shoulder range of motion was 105° flexion, 40° extension, 60° abduction, 80° internal rotation, and 35° external rotation. The patient had positive Hawkins Signs and pain with acromioclavicular joint compression, bilaterally. Spurling signs were negative. Radiographs were unremarkable. Magnetic resonance imaging (MRI) showed bilateral thickening and edema of the inferior glenohumeral ligaments with loss of fat in the rotator interval, which is observed in adhesive capsulitis. While the physical examination and MRI findings of edema within inferior glenohumeral ligament are strongly consistent with adhesive capsulitis, other shoulder pathologies were considered. Arthritis and rotator cuff tears were ruled out by imaging. The patient-reported history, as well as physical examination findings, was not consistent with bursitis or tendonitis. Parsonage-Turner Syndrome was also considered since there was bilateral involvement. However, the physical examination did not identify signs or symptoms of weakness or sensory changes consistent with a diagnosis of Parsonage-Turner Syndrome. The patient was referred to physical therapy and had bilateral fluoroscopic-guided glenohumeral corticosteroid injections of 1 mL of 40 mg/mL Depo-Medrol (methylprednisolone acetate) and 4 mL 0.5% ropivacaine. Three months following the corticosteroid injections, the patient had marked improvements in shoulder range of motion and strength.  This is the first case to demonstrate that vaccinations may induce a systemic immune response resulting in bilateral adhesive capsulitis. Needle trauma related to the injection technique is unlikely to have caused the bilateral adhesive capsulitis as the limb contralateral to the injection was also involved. An immune-mediated response to the influenza vaccination is believed to be the cause.  At the time of this report, he outcome of the event adhesive capsulitis of shoulder' was resolving.  The event of adhesive capsulitis of shoulder' was assessed as serious due to criteria of medically significance, per company.  The reporter assessed the event of adhesive capsulitis of shoulder' related to the INN Flu vaccine seasonal.  Company comment:The patient developed the event of periarthritis unknown time after vaccination with the suspect vaccine, INN Flu Vaccine Seasonal. Chronology is unclear. Reportedly, the patient received an influenza vaccine high up on the shoulder (explicitly coded as 'Vaccine administered at inappropriate site'). The patients' medical history and concomitant medications were not reported. With information presented, causality is assessed as unassessable for the event of periarthritis. Causal relationship for product administered at inappropriate site is assessed as not related per company conventions.; Reporter's Comments: This is the first case to demonstrate that vaccinations may induce a systemic immune response resulting in bilateral adhesive capsulitis. An immune-mediated response to the influenza vaccination is believed to be the cause.; Sender's Comments: The patient developed the event of periarthritis unknown time after vaccination with the suspect vaccine, INN Flu Vaccine Seasonal. Chronology is unclear. Reportedly, the patient received an influenza vaccine high up on the shoulder (explicitly coded as 'Vaccine administered at inappropriate site'). The patients' medical history and concomitant medications were not reported. With information presented, causality is assessed as unassessable for the event of periarthritis. Causal relationship for product administered at inappropriate site is assessed as not related per company conventions.