Received Aug 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
Severe multisystem inflammatory response; Glomerular disease; Progressive respiratory failure; Permanent vision loss; Systemic immune dysfunction; Disabling neurological complications; Permanent organ damage; Experienced a rapid and devastating decline in health; This spontaneous case was reported by a consumer and describes the occurrence of MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (Severe multisystem inflammatory response), GLOMERULONEPHROPATHY (Glomerular disease), RESPIRATORY FAILURE (Progressive respiratory failure), BLINDNESS (Permanent vision loss), IMMUNE SYSTEM DISORDER (Systemic immune dysfunction) and NERVOUS SYSTEM DISORDER (Disabling neurological complications) in a 44-year-old patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (Severe multisystem inflammatory response) (seriousness criterion medically significant), GLOMERULONEPHROPATHY (Glomerular disease) (seriousness criterion medically significant), RESPIRATORY FAILURE (Progressive respiratory failure) (seriousness criterion medically significant), BLINDNESS (Permanent vision loss) (seriousness criterion medically significant), IMMUNE SYSTEM DISORDER (Systemic immune dysfunction) (seriousness criterion medically significant), NERVOUS SYSTEM DISORDER (Disabling neurological complications) (seriousness criterion medically significant), ORGAN FAILURE (Permanent organ damage) and GENERAL PHYSICAL HEALTH DETERIORATION (Experienced a rapid and devastating decline in health). At the time of the report, MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (Severe multisystem inflammatory response), GLOMERULONEPHROPATHY (Glomerular disease), RESPIRATORY FAILURE (Progressive respiratory failure), BLINDNESS (Permanent vision loss), IMMUNE SYSTEM DISORDER (Systemic immune dysfunction), NERVOUS SYSTEM DISORDER (Disabling neurological complications), ORGAN FAILURE (Permanent organ damage) and GENERAL PHYSICAL HEALTH DETERIORATION (Experienced a rapid and devastating decline in health) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication use information was not provided by reporter. It was reported that they never provided full and truthful disclosure of known risks, nor afforded a meaningful opportunity to decline without severe consequences. The patient was at risk for both lung and kidney transplants, dependent on supplemental oxygen, and required coordinated care from over 14 medical specialties and ongoing high-cost treatments. There was no family history or genetic predisposition to the autoimmune and systemic complications that currently faced by the patient. The patient's condition arose in direct temporal proximity to the Moderna vaccine and progressed immediately thereafter. The patient's treating physicians supported this causal link. It was reported that the patient sustained a permanent medical disability, loss of life insurance eligibility, loss of retirement security and earning potential, ongoing costs of care (infusions, transplant evaluation, mobility aids, etc.), and irreversible harm to physical and mental health. Treatment medication name was not reported.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.