Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Joint effusion, Laboratory test abnormal
Clinical narrative: Shoulder pain (due joint disorder)/left shoulder pain; Brusitis of left shoulder; Left shoulder partial subsacpular tear/Impingement of left shoulder/infraspinatus tendinosis; trouble doing normal daily tasks; trouble sleeping at night due to pain; trouble sleeping at night due to pain; Tenderness; Osteoarthritis of left shoulder/acromioclavicular osteoarthritis; Inability of shoulder joint; Rupture of left shoulder; interstitial tear of the supraspinatus; pain radiates to neck to forearm; pain radiates to neck to forearm; mild biceps tendinosis; subscapularis tendinosis; small glenohumeral joint effusion; Unable to use left arm; This serious case was reported by a consumer and described the occurrence of shoulder pain (due joint disorder) in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 753EJ, expiry date 26-AUG-2023) for prophylaxis.   The patient's past medical history included breast cancer and mastectomy. Concurrent medical conditions included cigarette smoker (every day smoker, 2 packs a day) and alcoholic (social drinker and occassional). Family history included cancer.   On 29-JUN-2022, the patient received Shingrix (intramuscular, left deltoid) .5 ml. On 29-JUN-2022, less than a day after receiving Shingrix, the patient experienced shoulder pain (due joint disorder) (Verbatim: Shoulder pain (due joint disorder)/left shoulder pain) (serious criteria hospitalization and disability). On an unknown date, the patient experienced shoulder bursitis (Verbatim: Brusitis of left shoulder) (serious criteria disability), rotator cuff syndrome (Verbatim: Left shoulder partial subsacpular tear/Impingement of left shoulder/infraspinatus tendinosis) (serious criteria disability), activities of daily living impaired (Verbatim: trouble doing normal daily tasks) (serious criteria disability), difficulty sleeping (Verbatim: trouble sleeping at night due to pain) (serious criteria disability), pain (Verbatim: trouble sleeping at night due to pain) (serious criteria disability), tenderness (Verbatim: Tenderness) (serious criteria disability), shoulder osteoarthritis (Verbatim: Osteoarthritis of left shoulder/acromioclavicular osteoarthritis) (serious criteria disability), shoulder discomfort (Verbatim: Inability of shoulder joint) (serious criteria disability), shoulder ligament rupture (Verbatim: Rupture of left shoulder) (serious criteria disability), arm discomfort (Verbatim: Unable to use left arm) (serious criteria disability), tendon rupture (Verbatim: interstitial tear of the supraspinatus) (serious criteria disability), pain in arm (Verbatim: pain radiates to neck to forearm) (serious criteria disability), neck pain (Verbatim: pain radiates to neck to forearm) (serious criteria disability), tendinosis (Verbatim: mild biceps tendinosis) (serious criteria disability), subscapularis (muscle) strain (Verbatim: subscapularis tendinosis) (serious criteria disability) and effusion of joint of shoulder region (Verbatim: small glenohumeral joint effusion) (serious criteria disability). The patient was treated with salicylic acid, triamcinolone acetonide (Kenalog) and meloxicam. The outcome of the shoulder pain (due joint disorder) and pain were not resolved and the outcome of the shoulder bursitis, rotator cuff syndrome, activities of daily living impaired, difficulty sleeping, tenderness, shoulder osteoarthritis, shoulder discomfort, shoulder ligament rupture, tendon rupture, pain in arm, neck pain, tendinosis, subscapularis (muscle) strain and effusion of joint of shoulder region were not reported and the outcome of the arm discomfort was resolved (duration 12 weeks).   It was unknown if the reporter considered the shoulder pain (due joint disorder), shoulder bursitis, rotator cuff syndrome, activities of daily living impaired, difficulty sleeping, pain, tenderness, shoulder osteoarthritis, shoulder discomfort, shoulder ligament rupture, arm discomfort, tendon rupture, pain in arm, neck pain, tendinosis, subscapularis (muscle) strain and effusion of joint of shoulder region to be related to Shingrix.     It was unknown if the company considered the shoulder pain (due joint disorder), shoulder bursitis, rotator cuff syndrome, activities of daily living impaired, difficulty sleeping, pain, tenderness, shoulder osteoarthritis, shoulder discomfort, shoulder ligament rupture, arm discomfort, tendon rupture, pain in arm, neck pain, tendinosis, subscapularis (muscle) strain and effusion of joint of shoulder region to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-JAN-2024 This report was submitted via the online direct entry reporting system.  The patient had left shoulder surgery.  The patient still had ongoing pain and disability. The reporter stated that that she had trouble doing normal daily tasks.  She had trouble sleeping at night due to pain. No use of left arm for 12 weeks. The patient's treatment medication included as Kenalog (2ml) (80 mgs of Kenalog), Meloxicam (7.5 mg) oral tablet. She would benefit from skilled PT to address the ROM and joint hypomobility, however patient preferred to perform HEP IND of PT (heparin induced of prothrombin time) due to her work schedule. The patient experienced left shoulder rotator cuff tear partial articular sided tear of the subscapularis and interstitial tear of the supraspinatus.  The left shoulder arthroscopy, surgery was performed on 2nd February 2023.