Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy kidney, Glomerulonephritis minimal lesion, Hydronephrosis, Nephrotic syndrome, Protein urine present
Clinical narrative: Kidney failure; Minimal Change Disease; nephrotic syndrome; fill with fluid/filling up with fluid; protein in urine/protein leaking into urine; filled with fluid, gained 27 pounds in three weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 80 year-old male patient received bnt162b2 (Formulation: Solution for injection), administered in arm right, administration date 04Feb2021 (Lot number: EN5318) at the age of 79 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Prior Vaccinations (within 4 weeks) no vaccine and no list of any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Covid 19 vaccine a Pfizer product, Caller states that protein leaking into urine started earlier, Caller states her husband got the vaccine. Caller states her husband's Nephrologist thinks the vaccine caused Minimal Change Disease, which led to nephrotic syndrome, which led to kidney failure. Caller states the kidney failure causes her husband to fill with fluid. Caller states the Minimal Change Disease is rare but it does happen. Caller states her husband's doctor told her to report the event. Second call notification given when Caller's husband gets on the call. Caller's husband states that he never had protein in his urine until after he got the shot. Caller's husband leaves call, and original Caller resumes report. Adverse Event: Kidney Failure: Minimal Change Disease, which led to nephrotic syndrome, which led to kidney failure. Kidney failure led to husband filling up with fluid and protein in urine. Caller states the progress came about slow. Outcome: Caller states her husband is improving with high doses of steroids. Caller states that before starting Prednisone, her husband was told it was normal to have side effects. Caller clarifies that her husband is having side effects from the prednisone but declines to specify events when probed. Caller states she has a pharmacy bottle, and cannot provide and NDC, Lot number and expiration date when probed. kidney biopsy Nov2021 diagnosed with Minimal Change Disease  The following information was reported: RENAL FAILURE (medically significant) with onset Nov2021, outcome "not recovered", described as "Kidney failure"; GLOMERULONEPHRITIS MINIMAL LESION (medically significant) with onset Nov2021, outcome "recovering", described as "Minimal Change Disease"; NEPHROTIC SYNDROME (medically significant) with onset Nov2021, outcome "recovering", described as "nephrotic syndrome"; PROTEIN URINE PRESENT (non-serious) with onset 2021, outcome "recovering", described as "protein in urine/protein leaking into urine"; WEIGHT INCREASED (non-serious) with onset 2021, outcome "unknown", described as "filled with fluid, gained 27 pounds in three weeks"; HYDRONEPHROSIS (non-serious) with onset Nov2021, outcome "not recovered", described as "fill with fluid/filling up with fluid". The events "kidney failure", "protein in urine/protein leaking into urine", "filled with fluid, gained 27 pounds in three weeks" and "fill with fluid/filling up with fluid" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: biopsy kidney: (Nov2021) diagnosed with minimal change disease; urine analysis: (2021) protein in urine; weight increased: (2021) 27 lbs, notes: gained 27 pounds in three weeks. Therapeutic measures were taken as a result of renal failure, glomerulonephritis minimal lesion, nephrotic syndrome, protein urine present, hydronephrosis.