Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Flank pain, Nephritis, Protein urine present, Ureteral stent insertion, Ureteric obstruction
Clinical narrative: This spontaneous case, was initially received on 08-Dec-2017, from a consumer, concerning a 58-year-old female, adult patient. The patient's historical condition included stones in right kidney (on an unspecified date) and it was removed (on an unspecified date in Sep-2017). It was reported that no stones found in left kidney. The patient's current conditions included, diabetes, obstructive sleep apnea and atherosclerosis since and unspecified date. The concomitant medications included CRESTOR, Diltiazem, valsartan, glipizide, omeprazole for unknown indications. The patient had history of flu shot in the past without any adverse events. On 24-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF34509, expiry date: 30-Jun-2018). On 25-Nov-2017, the patient experienced sudden flank pain on left side (reported as bad) thus, on the same day, the patient went to the ER. On the same day, the patient was hospitalized and underwent CT scan, which revealed inflammation of kidney and kidney stones were unchanged. No other tests were done. The patient was unable to void even for urine specimen; hence a Foley catheter was placed, but there was no urine output for 18 hours. Creatinine level was 1.5 initially and went up to 3.5 and potassium level was 5.9 (baseline value was unknown) on 25-Nov-2017. On 26-Nov-2017, the patient underwent bilateral stent insertion for ureter inflammation and urine flow (for obstruction). The patient was given IV. On 04-Dec-2017, creatinine level was 1.3, potassium was normal (value was not provided). Protein was observed in patient's urine. On 14-Dec-2017, the renal stents were planned to remove. At the time of this report, the patient had recovered from the event Inflammation of kidney and urine obstruction. The reporter considered the event inflammation of kidney as serious due to hospitalization and assessed the causality between the events and suspect vaccine as related. The reporter did not provided the seriousness and causality of the events creatinine increased, and potassium increased. Follow-up received from consumer on 09-Jan-2018: The current condition kidney stone was change to historical condition right kidney stone (which was removed in Sep-2017). The concomitant drug valsartan (started in Aug-2017, no dose changed) was withdrawn by the patient on an unknown date. It was reported that no tests other than CT was performed (ANCA antibody titer was not done) in ER and the consumer had no details of the diagnosis. Added events ureter inflammation and obstruction. The stents were placed for ureter inflammation and obstruction. Narrative was amended accordingly. Follow-up received from consumer on 25-Jan-2018: The consumer confirmed that patient had stones in right kidney only and reported that no stones were found in left kidney and it was confirmed that stents were placed due to ureter inflammation and obstruction. Narrative was amended accordingly.