Age: 74.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable consumer or other non HCP and a contactable nurse reporting on behalf of Physician. A 74-years-old male patient received PREVNAR 13 (Batch/Lot # J20347; exp: 01Jun2016), intramuscular in the left deltoid at 0.5 ml, single on 15May2015 at 12:27 pm from a family physician. The patient medical history included ongoing diabetes mellitus type II, ongoing chronic anemia, hypertension and hyperlipidaemia. Concomitant medication included ongoing LANTUS SOLOSTAR at 50U subcutaneous daily, ongoing glimepiride (unknown manufacturer, tablet) 4 mg with breakfast or the first main meal of the day oral once a day, ongoing atorvastatin calcium (unknown manufacturer, tablet) 20 mg oral once a day, Aspirin (tablet) 81 mg oral once a day, glucosamine chondroitin (unknown manufacturer) oral, COREG (tablet) at 6.25 mg with food oral twice a day, doxazosin mesylate (unknown manufacturer, tablet) oral 4 mg 1x/day, NOVOLOG FLEXPEN 100 unit/ml subcutaneous, irbesartan (unknown manufacturer, tablet) 300 mg 1x/day, hydrochlorothiazide (unknown manufacturer, tablet) 25 mg 1x/day, cephalexin (unknown manufacturer, capsule) oral 500 mg twice a day, ranitidine HCl (unknown manufacturer, tablet) 300 mg oral 1x/day, LIPITOR (tablet) 20 mg oral 1x/day, AMARYL (tablet) 4 mg oral 1x/day, metformin HCl (unknown manufacturer, tablet) 2000 mg oral 1x/day, gemfibrozil (unknown manufacturer, tablet) 600 mg oral 1x/day, SYNTHROID (tablet) 25 mcg oral 1x/day. The patient experienced his arm turned really red/redness on May2015 with outcome of recovered, still have joint pain as part of reaction to injection on an unspecified date in 2015 with outcome of not recovered, there was some muscle tenderness since he get it in his shoulder joint/still have muscle pain as part of the reaction to injection on 2015 with outcome of not recovered. The patient saw physician's assistant who gave him prescription for oral antibiotics for redness and swelling. On 21May2015 the patient experienced cellulitis, was discomfort there hurting/aching and swelling. The patient recovered from the events cellulitis, aching and swelling on 27May2015. These events required specific tests and/or treatment. The EKG showed sinus bradycardia with normal intervals, the inferior infarct, but was not changed from a previous EKG. Microfilament exam showed no evidence of neuropathy. The events did not require an emergency room visit. The patient provided information to the physician regarding the reported adverse event. Refer to physical therapy, meloxicam would be used if the pain was not controlled with the use of TYLENOL 650. Chest x-ray was planned and it would not show any masses, further workup from a GI standpoint would be done. Risk stratification would be done with stress test. The patient was referred to EGD for a possible Schatzki's ring, he was also due for colonoscopy. The physician considered there was a reasonable possibility that the event were related to suspect product. Follow-up (30Oct2015): New information received from a contactable nurse on behalf of physician included: administration details (route, anatomical site, date and hour, dosage, batch/lot# and exp date) cellulitis event, lab data. Follow-up attempts completed. No further information expected.