Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Arthropathy, Back pain, Bone disorder, Injection site joint movement impairment, Injection site pain
Clinical narrative: This case is part of 4 cluster cases and it's is linked to cases 2012-12607, 2013-06243 and 2013-06234 (same reporter, FLUZONE HIGH-DOSE No Preservatives 2012-2013 lot number U4496AA). Initial report received from a healthcare professional on 20 MAY 2013.  A 72-year-old male patient had received an intramuscular dose of FLUZONE HIGH-DOSE No Preservative 2012-2013 (lot number U4496AA, dose number was not reported) in right arm on 20 SEPTEMBER 2012. Chronic problems included dyspnea (used oxygen, had DOE with minimal activity, had trouble sleeping without oxygen), arthritis, diabetes mellitus (PCMR, location was endocrine, symptoms began a year ago, managed by diet and oral medication, sugars at home had been int he low 100s), abdominal aortic aneurysm,  chronic pancreatitis; congestive heart failure, hypertension, COPD, CAD and diverticulosis.  Location of arthritis pain was low back, right shoulder, bilateral wrist, bilateral hand, bilateral knee and bilateral ankle. Symptom was aggravated by activity and rest. Patient denied relieving factors and had activity limitations and fatigue. Pertinent negatives included rash and paresthesias. Past medical history included pulmonary embolism in 1999, chronic gastritis, compression T8, DVT, GERD, hyperlipidemia and myocardial infarction with stents. Surgical history included trigger point injections, appendectomy, cholecystectomy, abdominal herniorrhaphy in 1999. The patient was a former tobacco use5r. Patient had history of diarrhea due to Levothyroxine sodium. The patient received Pneumococcal vaccine in 08 SEPTEMBER 2010 and Tdap on 22 NOVEMBER 2011. Patient's concomitant medication included Lidocaine 2 percent and Celestone Soluspan 10 mg (1ml injected in right deltoid) during arthritis assessment, Metformin HCL 500 mg tablet oral 2 times morning and evening with meal, Imdur (Isosorbide Mononitrate) 20 mg orally every day before meal, Tramadol HCL 50 mg every 8 hours PRN for pain, Xanax (Alprazolam) 0.25 mg tablet orally 3 times a day OS, Nitrostat (Nitroglycerin) 0.5 mg to be taken as directed, Advir Diskus (Fluticasone propionate/Salmeterol) 250 mcg-50mcg 1 puff inhalation 2 times a day (morning and evening) and Suboxone (buprenorphine/Naloxone) 2mg +0.5 mg 1 tablet daily (started before visit). On 21 September 2013, the patient developed pain in right arm and right shoulder pain. Corrective treatment was not reported. On 15 MAY 2013, review of musculoskeletal system was positive for back pain and bone/joint symptoms; vital signs included blood pressure 141/73 mm/Hgh, pulse 92/mi and pain score 10/10; physical examination showed the patient had decreased ROM of both shoulders, right mid lateral should was tender to palpation. As of 20 MAY 2014, the patient had not recovered from the events. Documents held by sender: Patient hospital records. Follow-up information received from healthcare professional on 26 JUNE 2013. It was reported that, the patient was still having problems i.e. shoulder pain and vaccination site pain. The patient did not report this adverse event previously. As of 26 JUNE 2013, the outcome was not recovered.