Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Bursitis, Extraskeletal ossification, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Influenza vaccine-related subacromial/subdeltoid bursitis/Inflammation of the bursa; Tenosynovitis; Affected [range of motion,] activities of daily living; Affected [range of motion, activities of daily living and] sleep/Affected ability to sleep; Ossified chondrol body within the bicipital groove; Shoulder ultrasound showed small amount of residual fluid in the subacromial/subdeltoid bursa/A very small partial thickness, intra-substance tear was noted within the subscapularis tendon; MRI of the right shoulder showed Limited fluid sensitive sequences were obtained, including axial and coronal T2 fat saturation sequences/These sequences showed moderate T2 hyperintense signal abnormality within the subacromial/subdeltoid bursa; Radiographs of the right shoulder/There was a 9 mm ossification noted at the anterior aspect of the joint, which was interpreted as an ossified chondral body within the bicipital groove; Tenderness to palpation at the site of vaccine injection; Right upper arm pain extending from the injection site to the mid upper arm; Right upper arm pain extending from the injection site to the mid upper arm; Right shoulder pain/persistent shoulder pain, which worsened with overhead movements; Affected range of motion/Affected ability to limit motion during MRI acquistion; Skin erythema overlying the right acromioclavicular joint and superior aspect of the deltoid muscle; This is a serious literature case reported by other health professional, initially received on 22-Jul-2019, concerning a 72-year-old, elderly, female patient.   The patient did not have a known history of diabetes, rheumatoid arthritis or gout. The patient did not have a history of known trauma. Her physical activities included walking, yoga, and Pilates. Her occupation was as an office worker. The patient's current condition included hypertension.  On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (INFLUENZA VIRUS VACCINE polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for an unknown indication.  On an unspecified date, two weeks following administration of the influenza vaccination, the patient presented to an outpatient internal medicine clinic. The patient reported right upper arm pain extending from the injection site to the mid upper arm. No erythema, oedema, or neuropathic symptoms (motor weakness or sensory changes) were reported. The pain started following the injection and persisted up to the patient's presentation to internal medicine clinic. On physical exam, the patient displayed mild to moderate tenderness to palpation at the site of vaccine injection. No visible wound, erythema, or edema was noted at the injection site. The patient was instructed to take non-steroidal anti-inflammatory drugs, as needed, as well as to apply heat or ice packs to the region for pain relief. The patient returned to clinic two weeks after the initial appointment, with increasing right shoulder pain that had affected her range of motion, activities of daily living, and sleep. Given the worsening symptoms, the patient was referred to orthopedic surgery and was ultimately evaluated in the orthopedic clinic four weeks following vaccine administration. At that time, the patient complained of persistent shoulder pain, which worsened with overhead movements and now affected her ability to sleep. Physical examination demonstrated skin erythema overlying the right acromioclavicular joint and superior aspect of the deltoid muscle. Labs obtained at the time of the orthopedic surgery appointment, including a white blood cell count (WBC) of 9.1 K/uL (normal range: 3.8-10.8 K/uL) and erythrocyte sedimentation rate (ESR) of 6 mm/h (normal range: less than or equal to 15 mm/h) were normal.  Radiographs of the right shoulder obtained at the time of presentation to the orthopedic clinic showed no acute fracture or dislocation. There was a 9 mm ossification noted at the anterior aspect of the joint, which was interpreted as an ossified chondral body within the bicipital groove. The acromioclavicular and glenohumeral joint spaces were maintained. Given the patient's persistent symptoms at follow up appointments, a magnetic resonance imaging (MRI) of the right shoulder was subsequently obtained. MRI of the right shoulder was performed without intravenous contrast four weeks after the influenza vaccine administration. The patient continued to have severe pain at that time, which affected her ability to limit motion during the MRI acquisition. Limited fluid sensitive sequences were obtained, including axial and coronal T2 fat saturation sequences. These sequences showed moderate T2 hyperintense signal abnormality within the subacromial/subdeltoid bursa, reflecting inflammation of the bursa. Fluid was also noted within the bicipital groove, which was attributed to tenosynovitis. No glenohumeral joint effusion was noted. No other fluid collections or areas of T2 hyperintense signal abnormality were noted, whether in the muscles or bones. Follow-up diagnostic shoulder ultrasound was obtained approximately two weeks after the MRI. The exam showed small amount of residual fluid in the subacromial/subdeltoid bursa. The ossific body in the bicipital groove and fluid within the bicipital groove were re-demonstrated. A very small partial thickness, intra-substance tear was noted within the subscapularis tendon. A small partial thickness, articular sided tear in the infraspinatus tendon was noted at the footprint. No full thickness rotator cuff tear was noted.  The patient continued to have pain for 2 months following the vaccine administration and was therefore referred for ultrasound-guided injection of the subacromial/subdeltoid bursa. Under ultrasound-guidance, 2 cc of 1 percent lidocaine and 1 cc of 40 mg/mL depomedrol were injected into the subacromial/subdeltoid bursa. The patient's pain decreased from 5/10 to 1/10 following injection. At a follow-up appointment one month after the steroid injection, the patient noted significant improvement in her pain and range of motion. Baseline shoulder pain was reported to be 3/10 and the patient had resumed almost all activities of daily living that had been limited by the pain.  The outcome of all the events was recovering.  The author concluded that, radiologists should be aware of this complication to help guide recommendations for imaging of a patient with persistent post-vaccination shoulder pain. An MRI or ultrasound may be considered to evaluate for the following: osteonecrosis, osteitis, bursitis, or myositis. Bursitis was a nonspecific finding and other etiologies, including infectious, inflammatory, or traumatic, may be considered depending on the clinical setting. Given the prevalence of yearly vaccination, vaccine-related bursitis should be considered when no other etiology was evident.; Reporter's Comments: A 72-year-old female patient experienced vaccination site pain and symptoms of bursitis and tenosynovitis, 2 weeks after receipt of INN flu vaccine seasonal. Subsequently patient complained of insomnia, loss of personal independence in daily activities. Multiple lab diagnosis supported these diagnoses. Considering the plausible temporal relationship between vaccination and reported events, plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assessed the events vaccination site pain, bursitis and tenosynovitis as possibly related to suspect vaccine. The event extraskeletal ossification assessed as not related considering the temporal and biological implausibility with suspect vaccine. The event insomnia and loss of personal independence in daily activities assessed as not related, as these events can be alternately explained by underlying bursitis and tenosynovitis rather than suspect vaccine. The company assessed the case as serious (medically significant).