Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Alanine aminotransferase increased, Blood electrolytes normal, Blood potassium decreased, Blood thyroid stimulating hormone decreased, C-reactive protein increased
Clinical narrative: Initial report received from health authority (PEI2010010322) on 18 May 2010. This patient had a medical history of renal hypertension, inguinal herniotomy right-sided, immunosuppresion (with RAPAMUNE) and polycystic degeneration of the kidneys (familiar clustering). The patient was on maintenance suppressive therapy with RAPAMUNE, which was reported as co-suspect drug, for polycystic degeneration of the kidneys and was additionally under maintenance therapy with irbesertan 150 mg once daily, and metoprolol/hydrochlorothiazide combination 95 mg/ 12.5 mg, once daily. The patient was vaccinated with seasonal influenza virus vaccine (manufacturer and batch no unknown), dose unspecified on 28 Oct 2009. Following administration with vaccine, on the same day, the patient experienced pyrexia, chills and diarrhea (partially of bloody character). The patient also experienced flu-like symptoms on 28 Oct 2009. The patient was hospitalized on 30 Oct 2009. At hospitalization, RAPAMUNE was transitorily discontinued (date unspecified). Laboratory examinations (normal range were not provided) at admission (30 Oct 2009) revealed increased inflammatory parameters (compatible with acute infection)- C-reactive protein (CRP) at 7.2 mg/dl, Total WBC at 7.1 G/l with following differential formula (percentage) - neutrophils at 81.8%, lymphocytes at 11.8% and monocytes at 6.4%. Thyrotropin (TSH) basal value was decreased up to 0.137 mIU/l and platelet count was reduced to 86 G/l. The remaining values of the hematology red series were at the lower normal boundaries. Potassium level amounted to 3.4 mmol/l and the liver function tests showed marginal elevation of GPT. Renal function tests were normal. Faecal investigations revealed presence of Campylobacter jejuni in relevant numbers which amounted to 10000 U/ml (U/ml assumed to rather mean cfu/ml, i.e. colony forming units). The patient received treatment (date unspecified) with oral erythromycin, 500 mg three times daily (continued until 18 Nov 2009) and was also administered with i.v. infusions. ECG performed on 30 Oct 2009 and X-ray on 02 Nov 2009 showed no abnormalities except heart rate of 93 bpm (normal). Abdominal ultrasound was done on 02 Nov 2009 that showed increased size of both kidneys with multiple cysts, otherwise was normal. Continuous blood pressure monitoring was carried out over about 20 hours (30 Nov 2009 to 04 Nov 2009) that revealed arterial hypertension. Laboratory examinations prior to discharge (date unspecified) showed almost normalized CRP of 1.0 mg/dl and Total white blood cell (WBC) of 6.2 G/l with unremarkable differential formula. Further, platelet count was 170 G/l while protein electrophoresis, red series, kidney parameters and electrolytes were unremarkable. Urinary protein excretion was within normal range - less than 56 mg/24 hours equivalent to 2 mg/dl. On 06 Nov 2009, the patient was discharged in good clinical condition for further follow-up at his primary care physician. The outcome of the events was reported as complete recovery and the seriousness criterion was assessed as serious (hospitalization).