Sex: M
Vaccine: FLUX
Symptoms: Insomnia, Joint range of motion decreased, Laboratory test normal, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: This Literature - Spontaneous case, initially received on 28-Oct-2016, was reported by a health professional and concerns a 30-year-old male patient. Weight: not provided; Height: not provided. 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: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date soon after receiving an influenza vaccine, a previously healthy patient experienced adhesive capsulitis / frozen shoulder (medically significant, outcome: recovering / resolving). Associated symptoms included: Decrease in his range of motion, non-dominant left shoulder pain, sharp pain in the posterior subacromial region whenever he brought his arm up behind his head and tried to relax his elbow back / low-grade pain with activity / limited internal rotation (45 degrees) and external rotation (50 degrees) and stiffness. The patient presented with non-dominant left shoulder pain of approximately two years duration. According to the patient, the pain apparently began soon after receiving an influenza vaccine. Initially, he had trouble sleeping (outcome: not reported) and felt sharp pain in the posterior subacromial region whenever he brought his arm up behind his head and tried to relax his elbow back. This pain was accompanied with a decrease in his range of motion, but this did improve over a period of several months. Rotator cuff tears were ruled out by negative MRI findings. The history and physical exam findings were not suggestive of tendonitis or bursitis either. Although Parsonage-Turner Syndrome could also be a reason of unilateral shoulder pain post-vaccination, the history and physical exam lacked signs and symptoms of neuralgias, sensory changes, atrophy, and arm weakness. Other differential diagnoses were ruled out similarly, either by history, physical exam, or imaging. Relevant tests: Physical exam revealed good range of motion in forward flexion and abduction (150 degrees and 160 degrees, respectively) but limited internal rotation (45 degrees) and external rotation (50 degrees). He had a negative O'Brien test and mild to moderate pain with Hawkins maneuver. There was no pain with cross chest adduction or over the AC joint. He had 5/5 strength with Jobe test, resistive external rotation, belly-press, and bear-hug test. There was no atrophy around the deltoid or shoulder girdle, and there was no scapular winging. A radiograph of the shoulder showed that he had a type II acromion (outcome: not reported) with no joint abnormalities, no proximal migration of the humeral head, and no gross bony abnormalities. Clinical work-up for infection was negative. Treatment: Because the patient's pain and stiffness had been improving with time, it was decided that expectant management would be the course of action. The senior author recommended activity modification and NSAIDs (no steroidal anti-inflammatory drugs) along with rotator cuff strengthening program. He also recommended a cortisone injection (by a 1-in needle which was appropriate for his body weight) and symptomatic treatment with possible need for shoulder arthroscopy if no improvement was noticed. At this time, the patient has no limitations with his activities of daily living except for very low-grade pain with activity. Physical therapy was focused on pain control modalities and active/active-assisted ROM (range of movement), mostly performed on a home program 3 to 5 times per day. These exercises consisted of using finger-to wall climbing exercises, both front and sideways to improve forward flexion and abduction respectively, until symptoms subsided. Pendulum exercises and anterior/posterior capsular stretching were also included. Upon follow-up presentations, the patient was weaned away from supervised physical therapy and educated about a home program. Reporter's Comments: Reporter's assessment: The healthcare professional considered the events as related to the administration of Influenza Virus Vaccine (INN).  After having negative radiological findings and ruling out a number of other possible causes, it was concluded that the influenza vaccination led to the development of secondary shoulder stiffness as the patient reported that the pain started the day after they had the injection. The health care professional also stated that the location of the vaccine administration could be related as an injection too high in the deltoid can result in shoulder stiffness post-vaccination. It is not certain that the vaccination was the cause of the adhesive capsulitis. No further radiologic studies or arthroscopy was undertaken to evaluate the soft tissue or chondral components of the affected shoulders. Therefore, although we know the location of penetration, we do not know precisely the depth of the administration and therefore cannot conclude definitively that the adhesive capsulitis stemmed from improper injection. To the best of the knowledge of the healthcare professional, vaccination was the cause of shoulder stiffness. Sender's Comments: Listedness: Brand of Influenza vaccine not specified. Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, periarthritis, insomnia and abnormal x-ray findings are unlisted. Causality: Related. Time to onset was soon after receiving an influenza vaccine. Clinical examination and absence alternate pathology on MRI support the diagnosis of periarthritis or shoulder joint related to vaccine administration (SIRVA). The author admittedly could not confirm site of vaccine administration as being injection "too high in the deltoid". However the close temporal association, absence of prior shoulder disorder and exclusion of alternate etiology for events makes vaccination causally attributable only due to incorrect technique. Type 2 acromion on X-ray is considered to be an incidental finding unrelated to vaccine administration, hence considered not related to Influenza vaccine.