Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Biopsy kidney, Breakthrough COVID-19
Clinical narrative: Acute kidney injury; Breakthrough SARS-CoV-2 infection; This literature-non-study case was reported in a literature article and describes the occurrence of ACUTE KIDNEY INJURY (Acute kidney injury) in a 45-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:     The patient's past medical history included Kidney failure and Kidney transplant.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criterion medically significant) and BREAKTHROUGH COVID-19 (Breakthrough SARS-CoV-2 infection). The patient was treated with REMDESIVIR ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ACUTE KIDNEY INJURY (Acute kidney injury) was resolving and BREAKTHROUGH COVID-19 (Breakthrough SARS-CoV-2 infection) had resolved. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy kidney: revealed acute thrombotic microangiopathy (TMA) as well as an osmotic tubulopathy.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered ACUTE KIDNEY INJURY (Acute kidney injury) and BREAKTHROUGH COVID-19 (Breakthrough SARS-CoV-2 infection) to be related.    No concomitant medications were reported.  Patient was presented with a breakthrough SARS-CoV-2 infection complicated by an episode of acute kidney injury 26 months after transplant. Patient had minimum respiratory symptoms, pancytopenia, mild hematuria, and proteinuria.   It was reported, acute thrombotic microangiopathy was favored to be secondary to the SARS-CoV-2 infection.  The osmotic tubulopathy was favored to be secondary to remdesivir therapy, specifically related to the sulfobutylether-beta-cyclodextrin solubilizing carrier agent used in its formulation.  The patient's kidney function had improved after resolution of the SARS-CoV-2 infection.  CC: This literature non-study case concerns a 45 year old female patient, with a relevant history of kidney transplant and kidney failure, who experienced the serious (medically significant) unexpected adverse event Acute kidney injury (AESI), and the non-serious AESI of Breakthrough COVID-19, which occurred unknown days after the second dose of mRNA-1273 vaccine administration. Patient was presented with a breakthrough SARS-CoV-2 infection complicated by an episode of acute kidney injury 26 months after transplant. Patient had minimum respiratory symptoms, pancytopenia, mild hematuria, and proteinuria. Biopsy kidney result revealed acute thrombotic microangiopathy (TMA) as well as an osmotic tubulopathy. It was reported, acute thrombotic microangiopathy was favored to be secondary to the SARS-CoV-2 infection. The osmotic tubulopathy was favored to be secondary to remdesivir therapy, specifically related to the sulfobutylether-beta-cyclodextrin solubilizing carrier agent used in its formulation. The patient's kidney function had improved after resolution of the SARS-CoV-2 infection. The ongoing COVID-19 pandemic  and underlying history of kidney transplant and kidney failure could be confounders for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This literature non-study case concerns a 45 year old female patient, with a relevant history of kidney transplant and kidney failure, who experienced the serious (medically significant) unexpected adverse event Acute kidney injury (AESI), and the non-serious AESI of Breakthrough COVID-19, which occurred unknown days after the second dose of mRNA-1273 vaccine administration. Patient was presented with a breakthrough SARS-CoV-2 infection complicated by an episode of acute kidney injury 26 months after transplant. Patient had minimum respiratory symptoms, pancytopenia, mild hematuria, and proteinuria. Biopsy kidney result revealed acute thrombotic microangiopathy (TMA) as well as an osmotic tubulopathy. It was reported, acute thrombotic microangiopathy was favored to be secondary to the SARS-CoV-2 infection. The osmotic tubulopathy was favored to be secondary to remdesivir therapy, specifically related to the sulfobutylether-beta-cyclodextrin solubilizing carrier agent used in its formulation. The patient's kidney function had improved after resolution of the SARS-CoV-2 infection. The ongoing COVID-19 pandemic  and underlying history of kidney transplant and kidney failure could be confounders for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.