Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Focal segmental glomerulosclerosis
Clinical narrative: Developed severe collapsing focal & segmental glomerulosclerosis; COVID-19 infection; This literature-non-study case was reported in a literature article and describes the occurrence of FOCAL SEGMENTAL GLOMERULOSCLEROSIS (Developed severe collapsing focal & segmental glomerulosclerosis) in a 57-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.      The patient's past medical history included Kidney transplant (Patient was homozygous for APOL1 risk alleles) and Hemodialysis.   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 (Developed severe collapsing focal & segmental glomerulosclerosis) (seriousness criterion hospitalization) and COVID-19 (COVID-19 infection). At the time of the report, FOCAL SEGMENTAL GLOMERULOSCLEROSIS (Developed severe collapsing focal & segmental glomerulosclerosis) and COVID-19 (COVID-19 infection) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Authors presented a case of a kidney transplant recipient who was homozygous for APOL1 risk alleles on low-dose immunosuppression who developed an antibody response to COVID-19 vaccination and subsequently acquired COVID-19 infection. Although patient experienced relatively minor effects in other organ systems, she developed severe collapsing focal segmental glomerulosclerosis that left her dependent on hemodialysis on hospital discharge.   Authors suggested that COVID-19 vaccination may not provide protection from infection-associated focal segmental glomerulosclerosis in patients with APOL1 risk alleles.  Company Comment: This literature-non-study case, concerns a female patient aged 57 years, with relevant medical history of kidney transplant recipient who was homozygous for APOL1 risk alleles on low-dose immunosuppression reported, who experienced the unexpected serious (Hospitalization) event of Focal segmental glomerulosclerosis and unexpected non serious event of Covid-19 that occurred in the context of unspecified dose of mRNA-1273 vaccination in covid-19 vaccination series. Latency cannot be assessed since vaccination date nor event onset date was disclosed. Patient developed an antibody response to COVID-19 vaccination and subsequently acquired COVID-19 infection. She experienced relatively minor effects in other organ systems, she developed severe collapsing focal segmental glomerulosclerosis that left her dependent on hemodialysis on hospital discharge. No further information on risk factors, co morbidities, detailed clinical course, management of the event and the outcome was available in the report.  Relevant medical history remains a confounder to the event Focal segmental glomerulosclerosis. Author suggests that COVID-19 vaccination may not provide protection from infection-associated focal segmental glomerulosclerosis in patients with APOL1 risk alleles. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This literature-non-study case, concerns a female patient aged 57 years, with relevant medical history of kidney transplant recipient who was homozygous for APOL1 risk alleles on low-dose immunosuppression reported, who experienced the unexpected serious (Hospitalization) event of Focal segmental glomerulosclerosis and unexpected non serious event of Covid-19 that occurred in the context of unspecified dose of mRNA-1273 vaccination in covid-19 vaccination series. Latency cannot be assessed since vaccination date nor event onset date was disclosed. Patient developed an antibody response to COVID-19 vaccination and subsequently acquired COVID-19 infection. She experienced relatively minor effects in other organ systems, she developed severe collapsing focal segmental glomerulosclerosis that left her dependent on hemodialysis on hospital discharge. No further information on risk factors, co morbidities, detailed clinical course, management of the event and the outcome was available in the report.  Relevant medical history remains a confounder to the event Focal segmental glomerulosclerosis. Author suggests that COVID-19 vaccination may not provide protection from infection-associated focal segmental glomerulosclerosis in patients with APOL1 risk alleles. The benefit-risk relationship of mRNA-1273 is not affected by this report.