Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Protein urine
Clinical narrative: Collapsing Focal Segmental Glomerulosclerosis (FSGS)/ acute kidney injury (AKI) with nephrotic range proteinuria; Acute Kidney Injury; This literature-non-study case was reported in a literature article and describes the occurrence of FOCAL SEGMENTAL GLOMERULOSCLEROSIS (Collapsing Focal Segmental Glomerulosclerosis (FSGS)/ acute kidney injury (AKI) with nephrotic range proteinuria) and ACUTE KIDNEY INJURY (Acute Kidney Injury) in a 24-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     Concurrent medical conditions included Human immunodeficiency virus syndrome. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for Human immunodeficiency virus syndrome.  On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced FOCAL SEGMENTAL GLOMERULOSCLEROSIS (Collapsing Focal Segmental Glomerulosclerosis (FSGS)/ acute kidney injury (AKI) with nephrotic range proteinuria) (seriousness criterion medically significant) and ACUTE KIDNEY INJURY (Acute Kidney Injury) (seriousness criterion medically significant). The patient was treated with METHYLPREDNISOLONE at an unspecified dose and frequency; MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) at an unspecified dose and frequency and LISINOPRIL at an unspecified dose and frequency. At the time of the report, FOCAL SEGMENTAL GLOMERULOSCLEROSIS (Collapsing Focal Segmental Glomerulosclerosis (FSGS)/ acute kidney injury (AKI) with nephrotic range proteinuria) and ACUTE KIDNEY INJURY (Acute Kidney Injury) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy kidney: revealed collapsing FSGS with 10% interstitial fibrosis and tubular atrophy. On an unknown date, Blood creatinine: 1.3 milligram per decilitre and 1.6 milligram per decilitre renal function worsened. On an unknown date, Investigation: outpatient work up for nephrotic syndrome was unrevealing. On an unknown date, Protein urine: 6 gram nephrotic range proteinuria under laboratory data.   The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered FOCAL SEGMENTAL GLOMERULOSCLEROSIS (Collapsing Focal Segmental Glomerulosclerosis (FSGS)/ acute kidney injury (AKI) with nephrotic range proteinuria) and ACUTE KIDNEY INJURY (Acute Kidney Injury) to be related.    This was case of collapsing glomerulopathy/FSGS in relationship with COVID-19 vaccine. It was unclear of what mechanism was attributed to FSGS, but it was possible to consider an inflammatory response against the spike protein as a second hit phenomenon to susceptible individuals, such as specific locals with APOL-1 risk alleles or HIV. A booster of COVID-19 vaccine was not recommended.  Company comment: This literature non-study case concerns an male patient aged 24 years with history of well controlled HIV on BIKTARVY, who experienced the serious (medically significant) unexpected, events of Focal segmental glomerulosclerosis and Acute Kidney Injury (AESI) about 2 months after an unspecified dose of mRNA-1273 vaccination. Patient was referred to nephrology for Acute kidney injury with Nephrotic Range Proteinuria. Outpatient work up for nephrotic syndrome was unrevealing. Renal functions worsened from Se. creatinine: 1.3 mg/dl to 1.6 mg/dl, with 6 gms of proteinuria. Renal Biopsy revealed collapsing Focal segmental glomerulosclerosis with 10% interstitial fibrosis and tubular atrophy. Patient was treated with Methylprednisolone, Mycophenolate and Lisinopril. Outcome of the events was not known. No further clinical information was available for medical review. Author concludes that it was possible to consider an inflammatory response against the spike protein as a second hit phenomenon to susceptible individuals, such as specific locals with APOL-1 risk alleles or HIV. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This  literature non-study case concerns an male patient aged 24 years with history of well controlled HIV on BIKTARVY, who experienced the serious (medically significant) unexpected, events of Focal segmental glomerulosclerosis and Acute Kidney Injury(AESI) about 2 months after an unspecified dose of mRNA-1273 vaccination. Patient was referred to nephrology for Acute kidney injury with Nephrotic Range Proteinuria. Outpatient work up for nephrotic syndrome was unrevealing. Renal functions worsened from Se. creatinine: 1.3 mg/dl to 1.6 mg/dl, with 6 gms of proteinuria. Renal Biopsy revealed collapsing Focal segmental glomerulosclerosis with 10% interstitial fibrosis and tubular atrophy. Patient was treated with Methylprednisolone, Mycophenolate and Lisinopril. Outcome of the events was not known. No further clinical information was available for medical review. Author concludes that it was possible to consider an inflammatory response against the spike protein as a second hit phenomenon to susceptible individuals, such as specific locals with APOL-1 risk alleles or HIV. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.