Sex: F
Vaccine: FLUX
Symptoms: Necrosis, Pain, Rotator cuff syndrome, Shoulder injury related to vaccine administration, Wrong technique in product usage process
Clinical narrative: tissue necrosis (atypical of synovial or bursal tissue); shoulder injury related to vaccine administration; limited range of motion as a result of pain; severe right shoulder pain; severe right shoulder pain; shoulder weakness; Rotator cuff bursitis/severe shoulder bursitis/extensive inflammation in the bursal space; Impingement syndrome; bursal foreign body reaction; bursal foreign body reaction; Wrong route of administration/bursal foreign body reaction; multiple redirections of the needle while injecting the vaccine; This case was reported in a literature article and described the occurrence of necrosis in a adult female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced necrosis (serious criteria GSK medically significant), shoulder injury related to vaccine administration, injected limb mobility decreased, injection site pain, shoulder pain, localized muscle weakness, shoulder bursitis, impingement syndrome, bursa disorder, foreign body reaction, wrong route of administration and wrong injection technique. The patient was treated with nsaid's (Nsaid), cortisone injection and non-drug therapy (Physical Therapy). On an unknown date, the outcome of the necrosis, shoulder injury related to vaccine administration, injected limb mobility decreased, injection site pain, shoulder pain, localized muscle weakness, shoulder bursitis, impingement syndrome, bursa disorder, foreign body reaction, wrong route of administration and wrong injection technique were unknown.   The reporter considered the necrosis, shoulder injury related to vaccine administration, injected limb mobility decreased, injection site pain, shoulder pain, localized muscle weakness, shoulder bursitis, impingement syndrome, bursa disorder and foreign body reaction to be related to Influenza vaccine.  Additional details were reported as follows: This case was reported in a literature article and described the occurrence of shoulder injury related to vaccine administration (SIRVA) in a female patient aged between 50 to 51 years, who was vaccinated with unspecified Influenza vaccine (manufacturer unknown) for prophylaxis.  The patient was right-handed schoolteacher. No information on patient's family history or medical history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified Influenza vaccine in right deltoid (Route of administration unknown; batch number not provided; dosage unknown). The age of vaccination was not provided. On an unspecified date, an unknown period after the vaccination, the patient reported 3 months of severe right shoulder pain. The patient described the experience as being traumatic because of multiple redirections of the needle while injecting the vaccine. The patient presented for evaluation of her right shoulder. The patient developed severe shoulder pain and weakness over the next 48 hours; the pain was most pronounced with attempted shoulder elevation. The patient was evaluated and diagnosed with rotator cuff bursitis and impingement syndrome. The patient presented with bursal foreign body reaction. Oral medication consisting of therapeutic doses of nonsteroidal anti-inflammatory drugs were prescribed but did not result in any appreciable benefit. The patient was subsequently treated with a cortisone subacromial injection and referred to physical therapy for rotator cuff-specific exercises. This resulted in only temporary reduction in her symptoms, so a magnetic resonance image (MRI) of the shoulder was ordered. The MRI revealed evidence of severe shoulder bursitis with a large volume of fluid and solid-appearing heterogeneous bodies that extended throughout the subacromial space. There was no evidence of rotator cuff tear. On review of the MRI, the patient was sent to the shoulder subspecialty clinic for evaluation. Her physical examination was unchanged from the initial visit. Specifically, the patient had significant evidence of shoulder bursitis and shoulder pain with minimal motion especially when attempted overhead. The patient had limited range of motion as a result of pain, this was most pronounced with attempted forward flexion and/or abduction. The patient's active elevation, neutral external rotation, and abduction were 90 degree, 25 degree, and 70 degree respectively. Her external rotation strength was 4/5 and the patient was neurovascularly intact. No erythema or warmth was noted. The patient had a positive empty can shoulder test. After discussion with the patient, it was determined that the best course of action would be to perform an extensive arthroscopic surgical debridement of her subacromial space and biopsy of heterogenous loose bodies noted on the MRI. Therefore, the patient underwent an arthroscopic shoulder debridement, subacromial bursectomy, and intraoperative cultures of the bursal tissue. At the time of surgery, the patient was noted to have extensive inflammation in the bursal space. In addition, the patient had multiple white, hardened caseous-appearing material in the shoulder. This material was distinct from the bursae. These relatively large bodies were evacuated from the shoulder subacromial space and sent for culture and histologic analysis. Next, the rotator cuff was evaluated and noted to be intact. Her glenohumeral joint was evaluated and found to have a normal appearance without any significant abnormality. The patient noted significant relief in her symptoms after surgery. At 3-month postoperative checkup, her active forward flexion, neutral external rotation, and abduction were 165 degree, 70 degree, and 130 degree, respectively. The patient had no pain with shoulder motion in any plane, and her external rotation strength at neutral was 5/5. The patient progressed through physical therapy without significant difficulty. Histologic analysis of the loose bodies was revealed to have reactive changes and with areas of tissue necrosis. This was noted to be atypical of synovial or bursal tissue. Cultures were negative for bacterial or fungal growth. The authors commented, "The deltoid is the primary site of administration of the inactivated influenza vaccine for children and adults. Transient pain at the injection site and deltoid muscle are the most common chief complaints after vaccine administration. However, persistent pain and limited range of motion are uncommon and should raise suspicion for a reactive inflammatory process in the shoulder joint. Since the mid-2010s, claims of SIRVA to the Compensation Program have increased substantially. In addition, orthopedic surgery has been shown to be the most common secondary provider in evaluation of SIRVA. Thus, it is pertinent that orthopedic surgeons are aware of the presentation and management of SIRVA. SIRVA should be suspected when a patient, without prior shoulder complaints, reports a history of rapid-onset, persistent shoulder pain possibly associated with weakness and decreased range of motion within 48 hours of vaccine administration. The literature shows that SIRVA is often related to vaccine administration too high'' in the deltoid muscle, which can increase the risk of injecting into the shoulder joint or bursa or improper injection angle or redirection as seen in our patient. These factors of improper deltoid muscle referencing, angle of injection, and needle selection have led several groups to propose vaccine administration guidelines specifically to prevent SIRVA. Of note, although SIRVA is most often caused by the influenza vaccine, it is not isolated to the inactivated influenza vaccine alone and has been shown to be caused by other vaccine types delivered in the deltoid muscle such as the pneumococcal polysaccharide (PPSV23), herpes zoster, Tdap (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis), and human papillomavirus vaccines. Our patient had the unique finding of hardened, chalklike flakes that represented reactive changes and fibrinoid necrosis that had not previously been described in the literature. It is likely that this was the resultant effect of inadvertent injection of influenza vaccine into the subacromial bursa. We recommend removal of these foreign bodies if surgery is performed." The authors concluded, "SIRVA is an uncommon complication of deltoid vaccine administration that can present with symptoms and imaging that mimic other etiologies of shoulder dysfunction. Failed conservative management could be treated with arthroscopic shoulder debridement of inflamed soft tissue and bone, while obtaining cultures and pathology to rule out infection. In addition, we recommend postoperative physical therapy to achieve functional and symptomatic recovery."