Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Rotator cuff syndrome, Shoulder injury related to vaccine administration, Shoulder operation, Sleep disorder, Tendon rupture
Clinical narrative: Ruptured biceps tendon that had healed to the anterior capsule resulting in mechanical impingement as well as subacromial bursitis/Full-thickness supraspinatus tear/A rotator cuff; Shoulder injury related to vaccine administration (SIRVA); Ruptured biceps tendon that had healed to the anterior capsule resulting in mechanical impingement as well as subacromial bursitis/Biceps tendon tear; Vaccine administration into the sheath of the biceps tendon/ MRI of the right shoulder without IV contrast which revealed a full-thickness tear; This literature case was received on 27-Dec-2021 reported by other healthcare professional and concerned a 53-year-old, female patient.  The patient's medical history and concomitant medications were not reported. The patient denied any allergies.  On an unspecified date, the patient was vaccinated with Influenza virus vaccine (brand not specified; anatomical location: right arm reported as the sheath of the biceps tendon, more medial and superior location on arm than usual/than the recommended location of the body of the deltoid 2 inches inferior to the acromion, route of administration, dose and indication: not reported) (explicitly coded as 'Product administration error'). The batch number was not reported.  On an unspecified date, two weeks after receiving influenza vaccine, the left-hand-dominant patient presented to an outpatient musculoskeletal clinic with right shoulder pain. She noted that her pain began immediately but severely worsened 24 hours after receiving an influenza vaccine. The patient described the location of the pain as being over the injection site. The pain was localized over the right anterolateral shoulder with intermittent radiation down the arm into the biceps. The patient described the pain as aching and throbbing and rated as moderate-to-severe in intensity. The patient reported in the first week of her pain that she had paresthesias of the entirety of the right hand that had since resolved. The pain was worsened by movements in all planes but especially with shoulder flexion, abduction, and internal rotation and when sleeping on the right arm. There was no associated weakness and she had no difficulty lifting any object. The patient reported ibuprofen initially provided moderate relief of her symptoms but was no longer effective. The patient did not try any topical medications or modalities. The patient denied any erythema, warmth, swelling, or bruising to her shoulder. The patient sought treatment in the emergency department previously and received an oral steroid which provided no relief of her symptoms. A physical exam of the right shoulder demonstrated revealed no abnormalities on gross inspection. There was no warmth to the joint or erythema noted. Palpation demonstrated point tenderness over the bicipital groove. There was no effusion, crepitus, or deformity. Passive and active range of motion were full but reproduced significant pain. Sensation and manual muscle testing of both upper extremities were unremarkable. Hawkins, Neer, Speeds, drop arm, and O'Brien's tests to the right shoulder were positive. Empty can testing was painful but had no associated weakness. Scarf testing to the right shoulder was negative. Prior to her referral to the mentioned office, a radiograph of the right shoulder revealed no acute fracture or dislocation with normal shoulder alignment and joint spaces. There was no unexpected radiopaque foreign body or damage to the soft tissues. In the mentioned clinic, a limited point-of-care sonographic evaluation revealed that the biceps brachii long head tendon appeared normal without tendinosis or tear noted. There was a hypoechoic and compressible fluid collection in the region just lateral to the bicipital groove between the biceps tendon and the deltoid likely in the subdeltoid bursa. The fluid collection had a central 2 mm hyperechoic focus concerning for inflammatory synechiae, which are defined as thin, fibrous bands of tissue. The patient was referred for magnetic resonance imaging (MRI) of the right shoulder without IV contrast which revealed a full-thickness tear of the supraspinatus tendon with mild tendon retraction and a partial-thickness tear of the infraspinatus tendon without muscular atrophy as well as a joint effusion with subacromial and subdeltoid fluid traversing the full-thickness supraspinatus tendon tear. Additionally, no tear of the long head of the biceps tendon was noted. There was no evidence of retained needle tip or abscess. There was no acute labral injury but concern for chronic degenerative changes of the posterior labrum. The working diagnosis for the patient was determined to shoulder injury related to vaccine administration (SIRVA) resulting in both a rotator cuff and biceps tendon tear. The patient initially wished to attempt a course of conservative management. After an unsuccessful six week trial of conservative management including nonsteroidal anti-inflammatory drugs (NSAIDs), ice, rest, and physical therapy, the patient opted for surgery. Surgical exploration of the shoulder revealed a ruptured biceps tendon that had healed to the anterior capsule resulting in mechanical impingement as well as subacromial bursitis. There were additional findings of a full-thickness supraspinatus tear and chronic degenerative changes of the posterior labrum. The infraspinatus, subscapularis, and teres minor were intact. A tenotomy and bursectomy were performed to improve function and the supraspinatus tendon was reattached to the greater tuberosity of the humerus. There was no retained foreign body found during the operation, the hyperechoic structure on ultrasonography was likely an inflammatory synechiae.   As per authors, SIRVA can result from tissue damage sustained from the improper injection. Ultrasonographic evaluation can localize the afflicted area, in this case, the biceps tendon showed findings consistent with tenosynovitis.   At the time of initial reporting, the patient was recovering from the events of tenosynovitis, biceps tendon rupture, rotator cuff syndrome, and shoulder injury related to vaccine administration, as reported the patient was subsequently enrolled in a course of post-operative physical therapy. For the first 3 weeks, the patient was non-weightbearing with pendulum range of motion exercises only. The therapy protocol progressed to an active assisted range of motion exercises focused on flexing and abducting the shoulder with the goal of achieving full active range of motion by post-operative week 8. Strengthening exercises were also prescribed during this period, progressing from hand-squeezing exercises to the use of exercise bands to limit stresses on the shoulder. Follow-up six months post-operatively revealed only mild pain overlying the posterior acromioclavicular joint (1-2/10). The patient had progressed in therapy to be able to lift items onto a shelf and perform biceps curls with mild resistance. The patient had not recovered from the event of 'cartilage damage', as reported the posterior labrum was not repaired due to the chronicity of the changes.  The reporter did not provide the causality to influenza vaccine. The case diagnosis was reported SIRVA resulting in both a rotator cuff and biceps tendon tear induced by inadvertent vaccine administration into the sheath of the biceps tendon. Biceps tenosynovitis could result from improper administration of vaccine. Diagnosis could be made with ultrasonography/imaging prompting surgical referral if necessary.   All events were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Literature reference:  Case updated on 24-Jan-2022: Correction made to information received on 27-Dec-2021: Labs added (physical examination and ultrasound sonography added). Events of 'biceps tendon rupture', 'impingement syndrome shoulder' and 'shoulder injury related to vaccine administration' were added and events of 'numbness in hand', 'pain in extremity' and 'shoulder pain' were deleted since the diagnosis was reported. Case was upgraded from non-serious to serious (medically significant) after initial medical assessment Narrative amended accordingly.   Additional information received on 18-Apr-2023: The reporter's information updated. Literature Information added. The lab data updated. Required ER Visit ticked on the Product tab. Anatomical location added as right arm. Ibuprofen was added as a treatment. Verbatim for all events updated. The event outcome for all events changed from 'Not Reported' to 'Recovering / Resolving'. Emergency Room Visit field ticked for all events. The narrative was amended accordingly. Coding for the event 'Product administered at inappropriate site' changed to 'Product administration error'. Event 'Tenosynovitis' removed.   Company comment: A 53-year-old patient was vaccinated with influenza virus vaccine polyvalent. Reportedly, the vaccine was administered, at more medial and superior location on arm then usual (explicitly coded as 'Product administration error'). Since vaccination, the patient had aching, throbbing and numbness of her hand as well as pain with shoulder movement. Two weeks after vaccination, the patient presented with right shoulder pain. The patient was referred for magnetic resonance imaging (MRI) of the right shoulder without IV contrast which revealed a full-thickness tear of the supraspinatus tendon with mild tendon retraction and a partial-thickness tear of the infraspinatus tendon without muscular atrophy. The surgical exploration revealed a ruptured biceps tendon that had healed to the anterior capsule resulting in mechanical impingement as well as subacromial bursitis. A tenotomy and bursectomy were performed to improve function. Information regarding medical history and concomitant medications was not provided. Product administered at inappropriate site is assessed as unrelated per company conventions. Causal role of the suspect vaccine is assessed as not related for the event tendon rupture due to biological implausibility. Causal role of the suspect vaccine for the events rotator cuff syndrome and shoulder injury related to vaccine administration is assessed as unlikely related (defaults to related in the safety database for reporting purposes) to suspect vaccine, considering reported vaccine administration error.; Sender's Comments: A 53-year-old patient was vaccinated with influenza virus vaccine polyvalent. Reportedly, the vaccine was administered, at more medial and superior location on arm then usual (explicitly coded as 'Product administration error'). Since vaccination, the patient had aching, throbbing and numbness of her hand as well as pain with shoulder movement. Two weeks after vaccination, the patient presented with right shoulder pain. The patient was referred for magnetic resonance imaging (MRI) of the right shoulder without IV contrast which revealed a full-thickness tear of the supraspinatus tendon with mild tendon retraction and a partial-thickness tear of the infraspinatus tendon without muscular atrophy. The surgical exploration revealed a ruptured biceps tendon that had healed to the anterior capsule resulting in mechanical impingement as well as subacromial bursitis. A tenotomy and bursectomy were performed to improve function. Information regarding medical history and concomitant medications was not provided. Product administered at inappropriate site is assessed as unrelated per company conventions. Causal role of the suspect vaccine is assessed as not related for the event tendon rupture due to biological implausibility. Causal role of the suspect vaccine for the events rotator cuff syndrome and shoulder injury related to vaccine administration is assessed as unlikely related (defaults to related in the safety database for reporting purposes) to suspect vaccine, considering reported vaccine administration error.