Age: 46.0
Sex: M
Vaccine: FLUX, FLUX, FLU3, FLUX
Symptoms: Injection site pain, Joint range of motion decreased, Joint resurfacing surgery, Musculoskeletal discomfort, Musculoskeletal pain
Clinical narrative: This case was reported in a literature article and described the occurrence of progressive osteolysis and surface chondrolysis of the proximal humerus in a 46-year-old male subject who was vaccinated with Influenza vaccine (unspecified, manufacturer unspecified). The subject's medical history included a complete recovery from an open Bankart repair performed 13 years previously. No recent trauma was reported and the left shoulder had been asymptomatic preceding the vaccination. The subject was healthy, with no medical comorbidities, and reported no previous corticosteroid use or alcohol abuse. On an unspecified date the subject received unspecified dose of Influenza vaccine unspecified (intramuscular, left deltoid). Lot number not provided. Immediately after vaccination with Influenza vaccine unspecified, the subject experienced left shoulder pain and discomfort at left shoulder a few days later. The subject presented with shoulder pain and limited range of motion 3 weeks following vaccination in the deltoid area. No skin changes were noted, inflammatory markers were normal, and the shoulder pain and disability persisted despite non-steroidal anti-inflammatory drugs and occupational therapy. The pain was localized to the anterior shoulder joint and was exacerbated with overhead activities. Initial examination demonstrated a healthy-appearing man with no excessive muscle mass or subcutaneous fat surrounding the shoulder girdle. No changes of the skin were noted. Forward flexion (150), external rotation (35 deg), and internal rotation (L2) were limited compared with the unaffected side (160 deg, 45 deg, T7, respectively). He had tenderness over the biceps tendon and deltoid laterally. O'Brien's and Speed's tests were positive. Laboratory results, including white blood cell count, C-reactive protein, and erythrocyte sedimentation rate, were normal. Plain radiographs revealed a small lytic area involving the greater tuberosity of the humeral head. Magnetic resonance imaging (MRI) showed abnormal uptake and cystic changes involving the greater tuberosity of the humeral head; repeat MRI at 5 months showed progression in the cystic changes. Diagnostic arthroscopy of the shoulder revealed a hyperemic joint capsule and extensive, full-thickness chondrolysis of the humeral head. Cystic biopsy demonstrated inflammatory cells and granulation tissue, consistent with foreign body response. Cultures were negative. Pathological examination of surgical specimens demonstrated inflammatory cells and granulation tissue, consistent with reactive disease or foreign-body response. The progressive humeral lesion and inflammatory component was attributed to a reaction following the influenza vaccination, most likely given intraosseously. In addition, the extensive humeral head chondrolysis and biceps tendonitis were likely an inflammatory reaction to the injection and contributed to the subject's dysfunction and pain. Postoperatively, the subject completed additional physical therapy and was weaned off all narcotics and NSAIDs. At most recent follow-up, 3 years postoperatively, the subject had pain-free ROM of the left shoulder and excellent alignment, and had returned to all activities. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved. In this case, it was uncertain whether chondrolytic changes of the humeral head were present or established at the initial arthroscopy more than10 years prior to influenza immunization. However, the subject's shoulder was asymptomatic and fully functional for more than 12 years prior to vaccination and became problematic following vaccination. The influenza immunization caused inflammatory changes in the shoulder joint as confirmed with arthroscopic visualization and histopathologic examination, which likely induced humeral head chondrolysis or converted an asymptomatic chondrolytic process to a symptomatic shoulder condition with limited mobility and function.