This case was received from a healthcare professional via another manufacturer on 12 October 2012. The following narrative in verbatim from that report: "Case Description: On 09JUL2012, a spontaneous report was received from a social worker on behalf of a physician regarding a 42 year old male patient who underwent a pancreas transplant with the use of PROGRAF therapy. The patient began tacrolimus therapy for kidney transplant immunosuppression on 02JUL2005. He was taking tacrolimus 1 mg capsules with directions to take 3 mg twice daily by mouth. Concurrent medications were not provided. On 07MAY2007 (also reported as 05JUL2005), he underwent a pancreas transplant. The outcome for the event was unknown. The reporter did not assess the seriousness or the causal relationship for the event and tacrolimus therapy. The medical reviewer assessed the event as medically significant. No additional information was provided. Additional information was received on 24JUL2012 in the form of medical records regarding the 37 (previously reported as 42) year old patient. Concomitant medications included NORVASC, LIPITOR, IMURAN, calcium with vitamin D, BACTRIM, aspirin, LOPRESSOR, PRILOSEC and prednisone. On an unreported date, he took tacrolimus, 2 mg twice daily (previously reported as 3 mg twice daily). On 06APR2012, his physician reported that he was doing well following kidney and pancreas transplant and had excellent function of both allografts. No additional information was provided. Additional information was received on 06AUG2012 from a social worker. On 08JUL2005 (previously reported as 02JUL2005), the patient started tacrolimus 6 mg daily (previously reported as 3 mg twice daily). On 06APR2012, he started tacrolimus 3 mg daily. He underwent pancreas transplant for diabetic neuropathy which was noted in 2005. The outcome of the event of diabetic nephropathy was not reported. Medical history included diabetes mellitus. An medical reviewer assessed the event of diabetic nephropathy as medically significant. No additional information was provided. Additional information received on 20AUG2012 indicated that the male had a history of end stage renal disease secondary to diabetic nephropathy, therefore the event of diabetic nephropathy was removed and added to history. Medical history included bilateral retinopathy, with right eye bleeding, neuropathy, hypertension, coronary artery disease, myocardial infarction with cardiac catheterization and single vessel stent placement, knee and foot surgery and endocrine Type 1. Risk factors included being an ex-smoker, history of alcohol intake, underweight and sedentary. Concomitant medications included LASIX, HUMALOG, ISORDIL, LANTUS insulin, magnesium plus protein supplement, CELLCEPT, and SIC. On an unspecified date, he experienced multiple dental caries and had a removal of all of his teeth. He was seen by a physician on 10MAR2006 and it was noted he was obsessed with his weight and was weighing himself 4-6 times daily. He was advised by his physician to stop obsessing over his weight and asked to gain approximately 10 pounds, and to increase his exercise activity. At the time of the visit, he was taking tacrolimus 3 mg in the morning, and 4 mg at night and his tacrolimus level was 9.4. He was noted to have excellent graft function and was active on a pancreas transplant list. No further information was provided. Additional information was received on 07SEP2012 in the form of medical records from a financial coordinator (previously reported as a social worker) on behalf of a physician. On an unspecified date, the patient started tacrolimus 2 mg in the morning and 3 mg at night. Other suspect medications included an influenza vaccine, and PNEUMOVAX. He underwent total tooth extraction due to dental caries (also reported as poor dentition) on 15SEP2005 and he recovered nicely from this. During a sick visit on 21OCT2005, he reported he received his flu vaccine recently and also received a pneumococcal vaccine one day prior to this visit. Since that time, he had developed fevers and awoke with a temperature of 102 degrees Fahrenheit on 21OCT2005. He also complained of some fatigue, generalized malaise, some chills, some mile headache and some nausea. The physician noted that he presented with fevers in the absence of any localizing findings. The reporting physician indicated that the vaccines he received could have been responsible for his fever. However, the possibility of infection did exist due to his chronic immunosuppressive state. He also had recently discontinued the use of his prophylactic antiviral and antifungal therapy. The outcome of the events of fever, possible infection, some fatigue, generalized malaise, some mild headache and some nausea were not reported. Concomitant medications included PLAVIX. The reporting physician did not provide a seriousness or causality assessment for the events of fever, possible infection, some fatigue, generalized malaise, mild headache and mild nausea and the medical reviewer assessed these events as non-serious. No additional information is expected. Additional information was received on 21SEP2012 from a physician. On 21OCT2005m he developed fever, possible infection, some fatigue and generalized malaise (previously reported OCT2005). A diagnostic work up was done which included a negative cytomegalovirus polymerase chain reaction (CMV PCR). He was afebrile, had no pedal edema or cervical adenopathy, and his chest was clear upon auscultation. The reporter assessed fever, possible infection, fatigue, generalized malaise, mild headache and nausea as due to influenza (flu) vaccination and not related to tacrolimus. No additional information is expected. Evaluator Comment: As the timeline is compatible, a causal role of tacrolimus cannot be excluded based on the information provided therefore causality is possible. Confounders not reported. Additional information received 24JUL2012 does not change prior causality assessment. Additional information received 06AUG2012 adds event diabetic nephropathy that is due to the underlying diabetes mellitus, not related to use of tacrolimus. Causality for pancreas transplant is unchanged as possible. Additional information received 20AUG2012 does not change prior to causality assessment. Added events of dental caries and obsession with his weight are due to human action, not related to use of tacrolimus. Additional information was received on 07SEP2012 providing the vents of pyrexia, fatigue, malaise, headache and nausea which, as they were temporarily associated with receipt of flu and pneumococcal vaccine, are not related to tacrolimus. The event infection was suspected for which a contributory role of tacrolimus is possibly related based on immunosuppressive properties. Documents held by sender: None.