Age: 60.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Bone marrow oedema, Erythema, Inflammation, Injection site erythema, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) from a Non Clinical Study Program, and then from a contactable physician. A 60-year-old female patient received PREVNAR 13 (Lot# J53435, Exp date Nov 2015), via an unspecified route of administration in the right deltoid, on 19Jan2015 at around 7 pm, at single dose. Relevant medical history included ongoing rheumatoid arthritis, basal joint arthroplasty, venous ligation left leg, ongoing palpitations, ongoing hypothyroidism, ongoing atherosclerosis, ongoing polymyositis, ongoing glomerulonephritis, ongoing rheumatoid arthritis, flu, patient was former smoker, osteoarthritis, dermatomyositis, hx of nephritis, borderline hypothyroidism, phlebitis superficial, allergy to sulfa which lead to hives, shingles, deep vein thrombosis (DVT), varicose vein, anxiety, interstitial lung disease, hand surgery, vein ligation and stripping, varicose vein surgery. In middle of night, on 20Jan2015 the patient had severe pain in her arm and she could not move it, clothes pressing on arm hurt and she woke her up at night when she turned over. It was very irritating. The next day she looked up on the web and she saw that they could be side effects; the pain was so hurt that in the morning she could not lift the cup of coffee to her mouth. Due to the events she took ADVIL 200 mg three times a day, in which she got some relief. However the patient reported that she could not take her medicines (methotrexate and salicylate) for rheumatoid arthritis as there could be some conflict of interaction with ibuprofen. The patient stated that on an unspecified date in 2015 she also had infection in her arm, very limited range of motion, redness. She had redness and swelling on her entire arm and shoulder where she got the injection and a lot of pain as well. Due to limited range of motion she was admitted to the hospital on an unspecified date in 2015. Treatment given for these events included ibuprofen 200 mg thrice a day for 3 weeks. On 03Feb2015 pain persisted with trouble moving shoulder and trouble elevating straight up. She had pain that awakened her. She had been taking ibuprofen at 600 tid without benefit. Current medications included folic acid (unspecified trade name) tablet, at 1 mg 2x/day; methotrexate (unspecified trade name) 2.5 mg tablet, at 5 tabs once a week; salsalate (unspecified trade name) 750 mg tablet, 1 tab 2x/day; alprazolam (unspecified trade name) 0.5 mg tablet, at 1 DF night time (PRN TID). Internal/external rotation radiographs of the right shoulder showed no evidence for acute fracture. The bones appeared demineralized. There was mild osteoarthritis at the acromioclavicular and glenohumeral joints. At shoulders; soft tissue swelling and erythema over right deltoid at superior aspect with pain. Patient had an intense local reaction to vaccination. The physician did not think this represented a bacterial infection but likely aseptic inflammation of the subcutaneous tissue and or subdeltoid bursa. Radiograph will be obtain. Ibuprofen was stopped. TYLENOL and MEDROL 4 mg, 21 mg tablets were started. On 04Feb2015 pain was overall unchanged. New medications prescribed included PRILOSEC 20 mg, oral, one pill once a day and MOBIC 7.5 mg tablet, oral, 2x/day. On 25Feb2015 MRI of right shoulder (without IV contrast) showed: Rotator cuff: There was moderate supraspinatus and infraspinatus tendinosis with a superimposed full-thickness tear of the supraspinatus tendon that measures approximately 0.9 cm in the AP dimension. There was approximately 1.2 cm of medial retraction of the torn tendon fibers. There was mild/moderate subscapularis tendinosis. There teres minor tendon is unremarkable. There was no significant fatty degeneration of the musculature. There is a small amount subacromial/subdeltoid bursa 1 fluid. Biceps tendon: Unremarkable. Glenohumeral joint: There was no detached/displaced labral tear. There was a large joint effusion with associated synovitis. There was a focal cortical defect along the posterior superior aspect of the humeral head subjacent to the humeral head articular surface and supraspinatus insertion. There was mild/moderate underlying bone marrow edema. These findings were suggestive of an erosion. Alternatively, this could represent a posttraumatic defect in the setting of anterior shoulder instability. The articular surfaces were otherwise intact. There was no intraarticular body. Acromioclavicular joint: There was mild arthrosis of the acromioclavicular joint with bony hypertrophy and capsular distention which indents on the supraspinatus myotendinous junction. There was no subacromial enthesophyte. There was no evidence of acute fracture or dislocation. The deltoid was unremarkable. The subcutaneous tissues were unremarkable. There were a few scattered axillary lymph nodes measuring up to 1.0 cm in short axis, nonspecific, likely reactive. Impression: small full-thickness supraspinatus tendon tear. Large joint effusion with synovitis with findings suggestive of an erosion along the posterior superior aspect of the humeral head. Alternatively, this could represent a Hill-Sachs lesion in the setting of anterior shoulder instability. On 02Mar2015 outpatient prescriptions included RHEUMATREX, 2.5 mg tablet, by mouth once a week; FOLVITE 1 mg tablet, by mouth daily; XANAX 0.25 mg tablet, by mouth nightly as needed; DISALCID 750 mg tablet, by mouth daily. Examination of the shoulder revealed lateral tenderness. There was a slight loss of terminal ranges of motion in all planes. There was pain with eccentric loading of the arm. There was no instability. There was mild deformity of the biceps. There was very good biceps strength. There is weakness on strength testing of the proximal shoulder girdle. There is no neurologic deficit present. There is no erythema present. The physician found out rotator cuff tear right shoulder, shoulder pain secondary to injection. The physician recommended physical therapy. It was unlikely that the patient will require surgery. She stated that she would not have surgery anyway. Return to office in 2 months. Outcome of events infection in arm, soft tissue swelling, intense local reaction to vaccination and aseptic inflammation of the subcutaneous tissue and or subdeltoid bursa was unknown, the patient was not recovered from the other reported events. She complained that she had constant pain and discomfort, she was right handed and she needed her arm. The reporting physician considered that PREVNAR 13 had a casual effect to the adverse event. Follow-up (20Mar2015): new information received from a contactable physician includes: lab data, medical history updated, treatment updated, causality, new events.