Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Muscle contractions involuntary, Muscle oedema, Musculoskeletal stiffness, Periarthritis, Product administered at inappropriate site
Clinical narrative: Adhesive capsulitis of the glenohumeral joint; Progressive monoarticular inflammatory arthritis/progressive erosive arthritis; Rotator cuff injury; Sleep disruption; The vaccine was administered just distal (approximately 1 cm) to the lateral margin of the acromion, which might have been administered in an intrabursal or possibly intraarticular location; This literature case was received on 16-Nov-2020 and concerned a 51-year-old, male patient.  The aim of this article was to present the effect of postvaccination injuries resulting in prolonged shoulder pain and dysfunction since musculoskeletal injury was an uncommon but usually self-limited complication of vaccine administration. A case of progressive inflammatory monoarthritis of the shoulder characterized by bone erosion, bursitis, and severe synovitis caused by an influenza vaccine administered to the ipsilateral deltoid region was presented.  The patient had no significant medical history and no known allergies. The patient was slender and physically ?t with body mass index of 21 kg/m2. The patient's past medications included annual influenza vaccinations for more than 20 years without incident. The patient's concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; anatomical location: ipsilateral deltoid region, 1 cm distal to the lateral edge of the acromion, dose and route of administration: not reported) (explicitly coded as 'Vaccine administered at inappropriate site') as annual influenza vaccination. The batch number was not reported. It was reported that the injection was administered with a 1- inch, 22-gauge needle.  On the same day, within two hours after receiving influenza virus vaccine polyvalent, the clinical symptoms began, and the patient presented with acute onset of left shoulder pain. Soon after the onset of pain, the shoulder became stiff with decreased internal and external rotation.  Over the next month, the patient noted continued progressive loss of range of motion and sleep disruption owing to pain, and progressive decline in function for 6 weeks period.   On an unspecified date, six weeks after receiving influenza virus vaccine polyvalent, magnetic resonance imaging (MRI) revealed a small focal area of cortical irregularity and indistinctness involving the posterolateral humeral head with surrounding bone marrow edema, suggestive of cortical erosion. A small amount of fluid and soft tissue thickening involving the overlying subacromial/subdeltoid bursa suggested mild focal bursitis. Increased T2 signal within the superficial fibers of the adjacent infraspinatus tendon was indicative of tendinopathy or tendon injury with bursal surface fibrillation. The findings were predominantly in close proximity to the site of vaccine administration. However, the edema within the infraspinatus tracked medially within the superficial fibers of the muscle belly. There was also mildly increased T2 signal within the inferior glenohumeral ligament, mild synovitis in the rotator interval, obliteration of the retrocoracoid fat, and thickening of the coracohumeral ligament, all of which are commonly seen in the clinical setting of adhesive capsulitis.  On an unspecified date, a clinical diagnose of adhesive capsulitis with progressive erosive arthritis related to vaccine administration was made, and the patient as given ice, nonsteroidal anti-inflammatory drugs and physical therapy.  On an unspecified date, a follow-up evaluation six months after the onset of pain revealed classic findings of adhesive capsulitis on physical examination. There was no erythema, soft tissue swelling, or reported history of fever. However, radiographs, computed topography (CT) and repeated MRI showed interval progression of the erosive changes (progression of cortical erosion) involving the posterior margin of the greater tuberosity.  MRI also revealed an increase in the surrounding bone marrow edema underlying the erosions, rotator cuff injury, enhancing glenohumeral and acromioclavicular joint synovitis, and progression of the imaging findings of capsulitis with an edematous and enhancing inferior glenohumeral ligament. The changes related to subacromial/subdeltoid bursitis had also increased, with increased bursal edema and moderate enhancement. Abnormal thickening and increased T2 signal within the infraspinatus tendon progressed, and there was new abnormal increased T2 signal extending anteriorly into the supraspinatus tendon without any interval trauma or inciting event after the initial MRI. The significant radiologic progression over the 9 months following symptom-onset raised concern for an infectious or inflammatory process.  On an unspecified date, erythrocyte sedimentation rate, C-reactive protein, and white blood cell count were normal. Analysis of rheumatoid factor and cyclic citrullinated peptide antibodies revealed negative results. A glenohumeral joint aspiration revealed no fluid. An indium white blood cell/sulfur colloid marrow scan and 3-phase technetium 99m-methyl diphosphonate bone scan revealed a focal area of white blood cell activity in the humeral head that was matched by sulfur colloid uptake, indicating that white blood cell uptake was due to activated bone marrow rather than infection. In addition, there was only mildly increased activity in the left humeral head on delayed phase bone scan which was also more consistent with an inflammatory or reactive process than osteomyelitis. Given the lack of fluid ('dry tap') on aspiration and the bone scan findings, septic arthritis and osteomyelitis were excluded from the differential diagnosis.   On an unspecified date, the patient was treated with an ultrasound-guided glenohumeral joint corticosteroid injection with 4 ml of bupivacaine and 40 mg of methylprednisolone.  On an unspecified date, within six weeks following the injection, the patient reported a decrease in pain and improved range of motion.  On an unspecified date, 11 months after receiving influenza virus vaccine polyvalent, the physical therapy was reinitiated, and the patient regained near full range of motion over the following year.  On an unspecified date, 32 months after the onset of symptoms, follow-up radiographs revealed no further progression of erosive changes and the symptoms resolved. The patient experienced near-complete recovery.  At the time of initial reporting, the patient was recovering from the events.  The authors assessed the events as related to influenza virus vaccine polyvalent. As reported, the progressive inflammatory monoarthritis of the shoulder characterized by bone erosion, bursitis, and severe synovitis caused by an influenza vaccine administered to the ipsilateral deltoid region. It is important for both clinicians and radiologists to be familiar with the possible severe or disabling complications that can arise from vaccine administration, especially when administered more proximally than is recommended in the upper third of the deltoid.   The events of 'adhesive capsulitis of shoulder', 'inflammatory arthritis' and 'rotator cuff injury' were considered to be medically significant by a Physician. Company comment: A 51-year-old, male patient was vaccinated with influenza virus vaccine polyvalent. On the same day, within two hours after receiving influenza virus vaccine polyvalent, the clinical symptoms began with shoulder pain. The shoulder became stiff with decreased internal and external rotation. Over the next month, the patient noted continued progressive loss of range of motion and sleep disruption owing to pain. Six weeks after receiving influenza virus vaccine polyvalent, magnetic resonance imaging (MRI) revealed findings suggestive for cortical erosion, rotator cuff injury and mild focal bursitis. The findings were predominantly in close proximity to the site of vaccine administration. On an unspecified date, a clinical diagnose of adhesive capsulitis with progressive erosive arthritis related to vaccine administration was made. The vaccine was administered just distal (approximately 1 cm) to the lateral margin of the acromion, which might have been administered in an intrabursal or possibly intraarticular location. Product administered at inappropriate site is assessed as unrelated per company conventions. The event of sleep disorder is assessed as not related to the suspect vaccine, since was associated with pain. Adhesive capsulitis of shoulder, inflammatory arthritis and rotator cuff syndrome are assessed as possibly related.; Reporter's Comments: The reporters assessed the events as related to influenza virus vaccine. They presented a case of progressive inflammatory monoarthritis of the shoulder characterized by bone erosion, bursitis, and severe synovitis caused by an influenza vaccine administered to the ipsilateral deltoid region.  it is important for both clinicians and radiologists to be familiar with the possible severe or disabling complications that can arise from vaccine administration, especially when administered more proximally than is recommended in the upper third of the deltoid.; Sender's Comments: A 51-year-old, male patient was vaccinated with influenza virus vaccine polyvalent. On the same day, within two hours after receiving influenza virus vaccine polyvalent, the clinical symptoms began with shoulder pain. The shoulder became stiff with decreased internal and external rotation. Over the next month, the patient noted continued progressive loss of range of motion and sleep disruption owing to pain. Six weeks after receiving influenza virus vaccine polyvalent, magnetic resonance imaging (MRI) revealed findings suggestive for cortical erosion, rotator cuff injury and mild focal bursitis. The findings were predominantly in close proximity to the site of vaccine administration. On an unspecified date, a clinical diagnose of adhesive capsulitis with progressive erosive arthritis related to vaccine administration was made. The vaccine was administered just distal (approximately 1 cm) to the lateral margin of the acromion, which might have been administered in an intrabursal or possibly intraarticular location. Product administered at inappropriate site is assessed as unrelated per company conventions. The event of sleep disorder is assessed as not related to the suspect vaccine, since was associated with pain. Adhesive capsulitis of shoulder, inflammatory arthritis and rotator cuff syndrome are assessed as possibly related.