Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Osteoarthritis, Pain, Shoulder injury related to vaccine administration, Sleep disorder, Synovial cyst
Clinical narrative: pain began 1 day after receiving an influenza vaccination in his left shoulder; severe point tenderness at the deltoid muscle, generalized tenderness about the left glenohumeral joint; mild acromioclavicular joint osteoarthritis; osseous edema; Tearing of the posterosuperior and posterior glenoid labrum with a large paralabral cyst was noted; labral tear; negatively impact his daily life at work and when trying to sleep; shoulder injury related to vaccine administration; 3-month history of left shoulder pain; Initial information received on 03-Oct-2022 by physicianregarding an unsolicited valid serious case issued from a literature article:  This case involves a 49 years old male patient who experienced shoulder injury related to vaccine administration (SIRVA) while receiving vaccine influenza quadrival A-B vaccine [fluzone quadrivalent] (latency: 1 day).  On an unknown date, the patient received a 0.5 mL dose of injectable influenza, quadrivalent, preservative-free (11V4; Fluzone Quadrivalent, Sanofi Pasteur), with the site of injection documented as within the left deltoid. A pharmacist at a large retail pharmacy administered the vaccine as part of the Immunization Program.  On an unknown date, the patient presented with a 3-month history of left shoulder pain (arthralgia). He reported that the pain (pain) began 1 day after receiving an influenza vaccination in his left shoulder. The patient's initial pain was significant for several days, improved slightly without resolving, and then progressively worsened during the next 2 months, prompting presentation to the emergency department (ED). He reported the occasional "giving out" of his left arm when crawling on all fours, as was sometimes necessary in his occupation as a heating, ventilation, and air-conditioning technician. The pain was worst with overhead movements, quantified by the patient as 6 of 10 in severity, and negatively impacted his sleep. The patient denied any associated neck pain, shoulder swelling, or redness. The patient endorsed a history of chronic left shoulder pain with certain overhead activities that he had had for several years but that was tolerable; however, his presenting symptoms were different in quality and severity. Physical examination findings on initial presentation were positive for severe point tenderness at the deltoid muscle, generalized tenderness about the left glenohumeral joint (tenderness), and diffuse pain with cross-chest abduction. Range of motion was full. Radiographs of the left shoulder obtained in the ED demonstrated mild acromioclavicular joint osteoarthritis (osteoarthritis) with otherwise no significant abnormality. The patient was discharged from the ED with prescriptions for naproxen 500 mg oral tablets and topical diclofenac-sodium 1% gel, as well as outpatient referral to orthopedic surgery. When the patient was seen in the orthopedic surgery clinic, he reported that the medications prescribed upon ED discharge had not improved his symptoms at all, and his symptoms were worse. He rated his pain as 8 of 10 in severity. Noncontrast magnetic resonance imaging (MRI) of the left shoulder demonstrated osseous edema (bone marrow oedema) within the posterolateral proximal humerus and humeral greater tuberosity at the level of the infraspinatus tendon insertion. Soft tissue edema was also seen within the teres minor tendinous insertion and subscapularis musculotendinous junction. Tearing of the posterosuperior and posterior glenoid labrum with a large paralabral cyst (synovial cyst) was noted. The initial MRI report listed metastatic disease as a differential diagnosis for the osseous findings, so whole-body bone scan was recommended to evaluate for additional regions of abnormal bone marrow. Technetium-99m- methyl diphosphonate whole-body bone scan obtained approximately 2 weeks following the initial orthopedic surgery consultation was negative for any asymmetric or abnormal uptake suspicious for malignancy. At a follow-up visit with orthopedic surgery following the shoulder MRI and bone scan, 4 months from the date of his influenza vaccination, the patient endorsed continued pain. Although he did not quantify the severity of the pain at this visit, he said it had continued to progress since the previous visit. The patient reported that his shoulder pain was never tolerable enough for him to participate in the physical therapy that was prescribed at the initial orthopedic surgery clinic visit. SIRVA was diagnosed based on the onset of symptoms relative to the influenza vaccination and the imaging findings. The team of treating physicians felt that the patient's longstanding, less-severe shoulder pain was attributable to the labral tear (cartilage injury) seen on MRI and potentially related to overuse or repetitive motion, given the patient's profession and no apparent history of inciting trauma. A therapeutic injection of 40 mg triamcinolone acetonide was administered via posterior approach into the subacromial bursa with the intent of providing symptom relief. Six months following the therapeutic shoulder injection, the patient reported no significant improvement in his symptoms that continued to negatively impact his daily life at work and when trying to sleep (loss of personal independence in daily activities). Action taken with vaccine influenza quadrival A-B vaccine: Not applicable for the event Shoulder injury related to vaccine administration.   Corrective treatment: Naproxen, diclofenac sodium, triamcinolone acetonide for the event Shoulder injury related to vaccine administration. Outcome: Not Recovered/ not resolved for the event Shoulder injury related to vaccine administration. Seriousness: Hospitalization, disability for the event Shoulder injury related to vaccine administration. Reporter causality: Related for the event Shoulder injury related to vaccine administration. Based upon the reported information, the role of vaccine cannot be assessed.; Sender's Comments: Sanofi company comment dated 10-OCT-2022: This case involves a 49 years old male patient who experienced shoulder injury related to vaccine administration (SIRVA) while receiving vaccine influenza quadrival A-B vaccine [fluzone quadrivalent]. Based on information received, the causal role of VACCINE cannot be excluded in the occurrence of the event due to compatible temporal relationship of ADR to the VACCINE. However, information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history excluding alternative etiologies for the reported event are needed to fully assess this case.