Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Orthosis user, Rotator cuff repair
Clinical narrative: This Literature - Spontaneous case, initially received on 21-Mar-2017, was reported by a health professional and concerns a 69-year-old female patient. Weight: not provided; Height: not provided. The patient was health at the time of vaccination and was right-handed dominant. She had no prior shoulder pain, injury or surgery in either shoulder. Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN) for indication not reported. Dose regimen: Not reported, Route of administration: Intratendonous. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date during influenza vaccination, the patient experienced rotator cuff tear / rotator cuff tendinitis / partial articular-sided tear of the supraspinatus with a delaminated component (medically significant, outcome: recovering / resolving). Associated symptoms included: left shoulder pain, severe pain during an influenza vaccination, synovitis, unable to lift her arm after  the injection (context of injected arm), weakness. On an unknown date, the patient experienced arthroscopic subacromial decompression (medically significant, outcome: recovering / resolving), transtendinous rotator cuff repair (medically significant, outcome: recovering / resolving). The patient presented to an orthopaedic clinic with left shoulder pain. The patient stated that she experienced severe pain during an influenza vaccination, and was unable to lift her arm after the injection. She was initially treated conservatively by her primary care physician with a subacromial corticosteroid injection and physical therapy for presumed rotator cuff tendinitis for 5 weeks; however, her pain and weakness persisted. The patient was able to pinpoint the influenza vaccination as the exact time when her shoulder pain began. An MRI (magnetic resonance imaging) with intra-articular contrast was performed which showed a high-grade, partial articular-sided tear of the supraspinatus with a delaminated component. The contrast further delineated the delaminated nature of the tear. The patient underwent arthroscopic subacromial decompression and transtendinous rotator cuff repair with a double-row, suture-bridge construct and mini-open subpectoral biceps tenodesis. At the time of surgery, she was found to have a severely delaminated, nearly complete rotator cuff tear with significant synovitis in the glenohumeral joint and bursitis in the subacromial space. The patient was immobilized in a shoulder abduction brace for 4 weeks, with physical therapy beginning the day after surgery for passive range of motion. The patient progressed well through her rehabilitation protocol and was doing well at 1-year follow-up with nearly full strength, no pain and full range of motion. The patient noted that the injection was performed [?]unusually high' in their shoulder directly underneath the lateral aspect of the acromion, and the needle was inserted as deeply as possible. The patient stated that an 'unusually long needle was used during the injection'.; Reporter comments: The patient sustained high-grade partial rotator cuff tears from intratendinous injection during attempted deltoid intramuscular injection for vaccination. To the reporter's knowledge, this is the first report of rotator cuff tear as a complication from intended intramuscular injection. Thimerosal's effect on tendon and synovial tissue has not been studied, however, it may be related to the rotator cuff tears, glenohumeral synovitis, and subacromial bursitis encountered in the present case.; Sender's Comments: Listedness: Brand of Influenza vaccine not provided. Assessment according to CCSI for CSL's Inactivated Influenza Virus Vaccine, Rotator cuff tear, Rotator cuff repair and Tenolysis are unlisted. Causality:  Related. Time to event onset is at time of vaccination. Patient had no prior shoulder problems. Patient noted injection was performed 'unusually high' in the shoulder directly underneath lateral aspect of the acromion, and needle inserted as deeply as possible. Rotator cuff tear was confirmed on MRI.  The events are consistent with Shoulder injury related to vaccine administration (SIRVA). SIRVA is sequelae of immune response to direct (inadvertent) intra-articular vaccine antigens. Causality is considered related to Influenza vaccination due to incorrect vaccination technique.