Received Mar 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 8080748 | IM |
Trigger type 1 diabetes; This spontaneous case was reported by a non-health professional and describes the occurrence of TYPE 1 DIABETES MELLITUS (Trigger type 1 diabetes) in a 16-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080748) for COVID-19 prophylaxis. No Medical History information was reported. On 26-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 50 microgram. On 07-Jan-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced TYPE 1 DIABETES MELLITUS (Trigger type 1 diabetes) (seriousness criterion medically significant). At the time of the report, TYPE 1 DIABETES MELLITUS (Trigger type 1 diabetes) had not resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No Concomitant medications provided by the reporter. No treatment medications provided by the reporter.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.