Received Nov 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 8146743 | IM |
Product malfunction which lead to a leak in the PFS; Product malfunction which lead to a leak in the PFS; Occupational exposure; No adverse effect; This spontaneous case was reported by an other health care professional and describes the occurrence of SYRINGE ISSUE (Product malfunction which lead to a leak in the PFS), DEVICE MALFUNCTION (Product malfunction which lead to a leak in the PFS), OCCUPATIONAL EXPOSURE TO PRODUCT (Occupational exposure) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 8146743) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 8146743) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced SYRINGE ISSUE (Product malfunction which lead to a leak in the PFS), DEVICE MALFUNCTION (Product malfunction which lead to a leak in the PFS), OCCUPATIONAL EXPOSURE TO PRODUCT (Occupational exposure) and NO ADVERSE EVENT (No adverse effect). At the time of the report, SYRINGE ISSUE (Product malfunction which lead to a leak in the PFS), DEVICE MALFUNCTION (Product malfunction which lead to a leak in the PFS), OCCUPATIONAL EXPOSURE TO PRODUCT (Occupational exposure) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. No concomitant medications were reported. The reporter reported a product malfunction which led to a leak in the PFS and was filed for occupational exposure. The patient did not experience any additional symptoms or events. The Device problem code for pre-filled syringe include FDA code 1250, IMDRF code A050401 which included Use of Device Problem. Treatment information was not reported.