Received Jun 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
One lady had neuropathy; This female subject of an unknown age was involved in an other study and received COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) for COVID-19 prophylaxis. The report describes a case of NEUROPATHY PERIPHERAL (One lady had neuropathy). No Medical History information was reported. On an unknown date, the subject received dose of COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (unknown route) 1 dosage form at an unspecified frequency. On an unknown date, the subject experienced NEUROPATHY PERIPHERAL (One lady had neuropathy) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (One lady had neuropathy) outcome was unknown. The action taken with COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (Unknown) was unknown. For COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (Unknown), the reporter did not provide any causality assessments. ID was reported as DCP-0420-25. Regulatory Authority name was reported as mRNA-1083 Life Cycle Management Concept Evaluation. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-786903 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-May-2025: Live follow up received that contains no new information. On 26-May-2025: Live follow up received that contains no new information. On 27-May-2025: Live follow up received that contains significant information includes added Regulatory Authority number and narrative was updated.; Reporter's Comments: The reporter causality for the event was not provided. The company causality was assessed conservatively as related to the vaccine in the context of limited information available. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786903:Female patient