Sex: F
Vaccine: PPV, UNK
Symptoms: Oedema, Oral candidiasis, Oral herpes, Packed red blood cell transfusion, Physical deconditioning
Clinical narrative: Carpal tunnel syndrome; pleural effusion; Pneumonia in both lungs; Strep pneumoniae bacteremia; hypomagnesemia; Severe deconditioning; Anaphylactic shock secondary to Avelox; Reactive empyema; Hypoxia; Upper gastrointestinal bleed; Volume overload/mild congestive heart failure.; developed anemia/Anemia, multifactorial.; hypotensive with blood pressure of 90/47; quite edematous throughout; hemoccult positive stools; urinary tract infection; oral thrush and herpes outbreak on her face and lips; oral thrush and herpes outbreak on her face and lips/Nasolabial herpes simplex virus outbreak; Malnutrition; Tachycardia; facial swelling; This spontaneous report was received from a physician referring to a 68-year-old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.      On 29-MAR-2005, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, frequency, route, lot# and expiration date were not reported) and diphtheria toxoid, pertussis vaccine (2 Lf; dose detail, frequency and route were not reported), both for prophylaxis. On an unknown date in the middle of October 2006, the patient developed fatigue. On 17-OCT-2006, the patient went to physician's office with cough and fatigue. The patient was diagnosed with a left sided pneumonia and was sent home on oxygen. On the same day, the patient had a single blood culture that was positive for streptococcal pneumonia. On 18-OCT-2006 (reported as two days previously), the patient had 41 % bands. On 19-OCT-2006, the patient developed carpal tunnel syndrome. On 20-OCT-2006, the patient had a temperature of 99.1, blood pressure 104/50, pulse 100, pulse oximetry (ox) 81% on room air and 91 % on three liters of oxygen. She had decreased breath sounds in both bases, more so on the left with dullness to percussion on the left. Blood urea nitrogen (BUN) was 52 and creatinine 1.7. White blood cell count was 7.7 (all units not provided). On the same day, the patient was admitted for bacteremia, pneumonia and pleural effusion. She was treated with ceftriaxone (ROCEPHIN) and moxifloxacin hydrochloride (AVELOX). On an unknown date in October 2006, the patient developed anaphylactic shock secondary to moxifloxacin hydrochloride (AVELOX). On an unknown date in October 2006 after the second hydrochloride (AVELOX) infusion, the patient developed facial swelling and then she became hypotensive with blood pressure of 90/47 (unit not provided). On an unknown date in October 2006, the patient became quite edematous throughout and was transferred to the Intensive Care Unit and received epinephrine with transient tachycardia. On an unknown date in October 2006, the patient had improved blood pressure and decreased edema. On an unknown date in October 2006, the patient started treatment with intravenous famotidine (PEPCID), diphenhydramine hydrochloride (BENADRYL) and a dose of intravenous methylprednisolone sodium succinate (SOLU-MEDROL). On an unknown date in October 2006, the patient continued on ceftriaxone sodium (ROCEPHIN) and azithromycin (ZITHROMAX). On an unknown date in October 2006, the patient continued to be febrile with temperatures up to 102 and 103 (unit not provided). On an unknown date in October 2006, a computerized tomography (CT) of the chest and decubital chest films were obtained, which showed signs concerning for empyema. The physician was consulted and performed a left sided thoracentesis, which was productive of a minimal amount of inflammatory fluid. On 25-OCT-2006, CT scan of the chest showed patchy infiltrate in the right upper and middle lobes with a small dependent effusion. There was collapse of the left lower lobe with large loculated left pleural effusion. On an unknown date in October 2006, left decubital chest films showed no layering. On 30-OCT-2006, the patient was taken for thorascopic surgery on the left lung with decortication and removal of a large amount of fibrous exudate. This showed no organisms. Multiple repeat blood cultures were also negative. On an unknown date in 2006, the did have hemoccult positive stools and developed anemia down to hematocrit of 24.9 (unit not provided). She was placed on pantoprazole sodium (PROTONIX) intravenously and hemoccult positive stools resolved. On an unknown date in 2006, the patient had problems with anemia and was transfused several units of packed red blood cells. On an unknown date in 2006, post thorascopic decortication, two chest tubes were placed and were left in for over a week. The patient's condition gradually improved although quite slowly. She remained febrile for several days after surgery. On an unknown date in 2006, the patient develop a urinary tract infection and was treated with piperacillin sodium (+) tazobactam sodium (ZOSYN). On an unknown date in 2006, the patient also developed oral thrush and herpes outbreak on her face and lips and was treated with fluconazole (DIFLUCAN), oral nystatin and acyclovir. On an unknown date in 2006 over the course of her stay in hospital, the patient was improved. On an unknown date in 2006, the patient also developed hypoxia, upper gastrointestinal bleed volume overload/mild congestive heart failure, malnutrition, thrush, tachycardia, hypomagnesaemia and severe deconditioning. The outcome of pneumonia was recovered on 13-NOV-2006. On an unknown date, the outcome of carpal tunnel syndrome was recovered. On unknown dates in 2006, upper gastrointestinal haemorrhage and hemoccult positive stools was recovered. The outcome of other events was recovering. The causality assessment between pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and all events was not provided.    Upon interval review, pneumonia in both lungs, reactive empyema, strep pneumoniae bacteremia, hypoxia, upper gastrointestinal bleed volume overload/mild congestive heart failure, anaemia and anaphylactic shock secondary to moxifloxacin hydrochloride (AVELOX) were determined to be medically significant.