Age: 51.0
Sex: M
Vaccine: TYP
Symptoms: Laboratory test normal, Pancreatic insufficiency, Parasitic blood test negative, Vitamin B12 absorption test normal
Clinical narrative: This spontaneous case report was received from a consumer (PVX2016-1142) on 11-Jul-2016. The report describes a 51-year-old adult male patient (weight: 205 lb/92.98 kg, and height: 74 in./187.96 cm) who experienced endocrine pancreatic insufficiency, pain in abdomen and diarrhoea following the administration of VIVOTIF capsules (lot no.: 3003104, expiry date: Jun 2016, and NDC no.: 58337-003-1). It was reported that the patient started the VIVOTIF therapy in the beginning of March (date unknown), and around a week after completing his course, the patient experienced pain in the abdomen and diarrhea. The patient was initially started on three courses of 'powerful' antibiotics as the physician thought it was some kind of bacterial or parasitic infection that he had developed with food from another country. However, all tests for infections came out negative. The patient was suspected to have pancreatitis. The patient then went through pancreas elastase test. In this test, his levels of enzyme were monitored. The test result was positive, and his enzyme levels were less than 75% of the normal. The patient was not hospitalized and was suggested to start enzyme supplement therapy, which he would start very soon. The patient went through health tests which came out normal every year. The patient was the best tennis player and usually swam. Upon the receipt of further information, the patient confirmed that he had not gone through any radiological tests; however, endoscopy and ultrasound procedures were scheduled for 03-Aug-2016. The patient went through fecal pancreatic elastase test, and the reading was 153 mcg/g. The patient confirmed that no classical tests for pancreatitis were performed; however, he had gone through nutrient absorption test 2 days ago. In this test, it was examined if he was absorbing proper vitamins, specifically, Vit D and Vit B12, and the results were normal. The patient confirmed that he is not yet diagnosed with pancreatitis and he just assumed that his symptoms indicate pancreatitis. The patient was diagnosed with endocrine pancreatic insufficiency on 24-Jun-2016. The patient's concomitant medications include simvastatin (20 mg a day for 10 years) for cholesterol. The action taken with VIVOTIF with respect to the events endocrine pancreatic insufficiency, pain in abdomen and diarrhea was not applicable. The outcome of the events endocrine pancreatic insufficiency, pain in abdomen and diarrhea was unknown. Reporter's Comments: In this case, the patient experienced endocrine pancreatic insufficiency, pain in abdomen and diarrhea following administration of VIVOTIF. Pain in abdomen and diarrhea appears to be symptoms of endocrine pancreatic insufficiency. The pancreatic insufficiency as diagnosed with faecal elastase test is a chronic condition. Further, the patient was having hypercholesterolemia for which he was taking simvastatin for almost 10 years. In view of the presence of risk factors (hypercholesterolemia) and the fact that the event is a chronic condition, there is an unlikely causal association between the event and the vaccine. Sender's Comments: In this case, the patient experienced endocrine pancreatic insufficiency, pain in abdomen and diarrhea following administration of VIVOTIF. Pain in abdomen and diarrhea appears to be symptoms of endocrine pancreatic insufficiency. The pancreatic insufficiency as diagnosed with faecal elastase test is a chronic condition. Further, the patient was having hypercholesterolemia for which he was taking simvastatin for almost 10 years. In view of the presence of risk factors (hypercholesterolemia) and the fact that the event is a chronic condition, there is an unlikely causal association between the event and the vaccine.