Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rhabdomyolysis, Specific gravity urine abnormal, Urinary incontinence, Urine analysis abnormal, White blood cell count normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. Copied from admission note : A 67 year old gentleman with hyperlipidemia(HL), hypertension(HTN), chronic obstructive pulmonary disease(COPD), osteoarthritis(OA), depression, obesity and alcohol use and history of ex-smoker and ex-drug user, tonsillar carcinoma, throat cancer with radiation treatment 1 year ago influenza vaccination who was transferred to Hospital for acute renal failure (ARF) and rhabdomyolysis. The patient stated that he was vaccinated SQ with the first dose of ZOSTAVAX (Merck) (lot #: 658209/1085U) into his left arm on Monday 19-NOV-2007. Concomitant therapy included albuterol (+) ipratropium bromide and aluminum hydroxide (+) diphenhydramine hydrochloride (+) lidocaine (+) magnesium hydroxide. On 21-NOV-2007, he began to feel bad. He states that he lost his balance and fell. This went away. On Thursday 22-NOV-2007 he developed a severe sore throat. He took some mouthwash that he had left over from when he was receiving treatment for tonsillar cancer and this helped. He also felt some nausea on Thursday. On Friday 23- NOV-2007, he developed right knee pain and could not get up out of bed. He wanted to "wait it out over the weekend" but felt horrible this am. He developed joint and muscle aches in his forearms, shoulders, ankles and right knee so he went to the hospital on 25-NOV-2007. He has not slept in 4 days. He has not eaten since Wednesday. He denied any visual changes or headaches. He denied890\ any vomiting or diarrhea/constipation. Denied fevers or chills. Denied abdominal or back pain, short of breath (sob), change in cough. It was reported that he went to the hospital and they gave his Intravenous Fluid ((IVF). He did urinate 200cc of brown urine there. Before that, he had not urinated since Friday. Currently he complained of joint aches and pains. The patient said that he does not feel up to walking around because he does not trust himself. Labs that were done included: white blood cell count (WBC) 6.29; hemoglobin (Hgb) 14.9; blood platelets 156; blood band neutrophil count 77%; blood segmented neutrophil count (segs) 17%; blood lymphocyte count 2%; Na 125 K 4.1, Cl 89, CO2 19; blood urea nitrogen test (BUN) 51; Creatinin13.8; Glucose 103; calcium (Ca) 8.9. May 2.3 erythrocyte sedimentation rate (ESR) 17; B; creatine kinase test (CK) : 5225; creatine kinase isoenzyme MB test (CKMB) 109.4; respiratory index (RI) 2.1. Myoglobin >4000 Trop .67. CT of head done which was negative for acute problem but did show mild atrophy. Blood cultures drawn. UA performed and was yellow, slightly cloudy, specific gravity 21.030, ph 5, protein 30, trace blood. The patient states that he did not use oxygen at home for COPD and occasionally uses inhalers. The patient has not had Pulmonary Function Test (PFTs) done and did have an adenosine cardiolyte which showed EF of 58% and small fixed perfusion defect. It was reported that the patient died. The adverse events were  considered to be life threatening. No further information is available. The VAERS ID number is 299062. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.