Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Biopsy kidney, Focal segmental glomerulosclerosis, Nephrotic syndrome, Peripheral swelling
Clinical narrative: Kidney issues; fsgs tip variant; Swelling abdomen; Swelling of legs; Nephrotic syndrome; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROTIC SYNDROME (Nephrotic syndrome) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) from 12-Jan-2020 to an unknown date for Anxiety, BACITRACIN (BACITRAYCIN PLUS) from 19-Apr-2021 to an unknown date for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced NEPHROTIC SYNDROME (Nephrotic syndrome) (seriousness criterion medically significant), ABDOMINAL DISTENSION (Swelling abdomen) and PERIPHERAL SWELLING (Swelling of legs). On 21-Jun-2021, the patient experienced FOCAL SEGMENTAL GLOMERULOSCLEROSIS (fsgs tip variant). On an unknown date, the patient experienced RENAL DISORDER (Kidney issues). The patient was treated with PREDNISOLONE (DELTASONE [PREDNISOLONE]) (oral) ongoing from 22-Jun-2021 for Adverse event, at a dose of 10 milligram every four hours; PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) (oral) ongoing from 22-Jun-2021 for Adverse event, at a dose of 40 milligram once a day; SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM DS) (oral) ongoing from 22-Jun-2021 for Adverse event, at a dose of 800-160 mg daily; METOLAZONE (ZAROXOLYN) (oral) on 24-Jun-2021 for Adverse event, at a dose of 2.5 milligram once a day and FUROSEMIDE (LASIX [FUROSEMIDE]) (oral) on 24-Jun-2021 for Adverse event, at a dose of 40 milligram three times a day. At the time of the report, NEPHROTIC SYNDROME (Nephrotic syndrome) had not resolved and RENAL DISORDER (Kidney issues), FOCAL SEGMENTAL GLOMERULOSCLEROSIS (fsgs tip variant), ABDOMINAL DISTENSION (Swelling abdomen) and PERIPHERAL SWELLING (Swelling of legs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jun-2021, Biopsy kidney: abnormal (abnormal) Diagnosed with FSGS (Focal segmental glomerulosclerosis) tip variant.         No treatment medication was reported by reporter.  Laboratory data includes blood work, urine samples, ultra sound and CT scan performed on 04-JUN-2021.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow-up received contains significant information. Events were added. Seriousness of the case changed as events are serious. Suspect drug dose details updated. Concomitant medications added. Patient demographics are added. Outcome of events Updated. Lab data is added. Medical history is added.; Sender's Comments: Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.