Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin, Immunology test, Renal amyloidosis, Urine analysis, Urine protein/creatinine ratio
Clinical narrative: RENAL AMYLOIDOSIS AL TYPE; This spontaneous report was received from other health professional via literature:  This report concerned a 76 year old male of an unspecified race and ethnic origin. The objective of the authors was to report a case of AL (Amyloid Light-chain) amyloidosis following Johnson and Johnson (J and J) SARS-CoV-2 vaccine. The patient's height, and weight were not reported. The patient's concurrent conditions included: amyloidosis (undiagnosed), and other pre-existing medical conditions included: The patient had no past medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced renal amyloidosis AL type.  The patient denied any rash, joint pains, change in appetite, use of NSAIDs (Non-steroidal anti-inflammatory drugs), PPIs (Proton pump inhibitors), antibiotics or herbal supplements.  It was reported that, the patient with no past medical history was evaluated for acute kidney injury (AKI) and lower extremity (LE) swelling. Patient mentioned that he started to notice LE swelling on 13th day after receiving J and J SARSCoV-2 vaccine, with associated presence of foamy urine and weight gain of 13 lbs since the receipt of the vaccine. Lab work showed serum creatinine (Scr) of 2.26 mg/dl (baseline Scr was 1.19 mg/dl, 2 weeks prior to receiving vaccine), low serum albumin (2.1gm/dl), anemia (Hgb 11.4 gm/dl) and hyperlipidemia. Urine analysis revealed greater than 600 mg/dl proteinuria, 37 RBCs with spot urine total protein/ creatinine ratio (TP/Cr) elevated to 8.6. Serum immunofixation showed IgA lambda band. He was initiated on oral torsemide. Kidney biopsy revealed renal amyloidosis AL type, lambda light chain restricted with extensive glomerular and vascular deposits (26% of glomeruli obliterated by amyloid). Subsequently, bone marrow biopsy also showed lambda chain amyloidosis. Scr peaked to 4.66 mg/dl, albumin was low at 2 gm/dl and spot urine TP/Cr was elevated at 13.3. He was initiated on treatment with Daratumumab and Cyclophosphamide, Bortezomib and Dexamethasone. 8 months into therapy, Scr and spot urine TP/Cr have decreased to 2.6 mg/dl and 2.8 respectively and serum albumin had normalized to 3.6 gm/dl. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of renal amyloidosis al type was not reported. The authors concluded that Vaccination was a recognized trigger for new-onset and relapse of glomerular disease. It appeared that the patient had undiagnosed amyloidosis, however the onset of nephrotic syndrome occurred after patient received the vaccine, likely secondary to enhanced immune response causing the disease to manifest clinically.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221213138-Renal amyloidosis AL type. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.