Received Oct 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052549 | IM |
No adverse effect; more than half of the dose came out as I tried to remove the cap to attach the needle.; This spontaneous case was reported by a nurse and describes the occurrence of SYRINGE ISSUE (more than half of the dose came out as I tried to remove the cap to attach the needle.) 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. 3052549) for COVID-19 prophylaxis. Suspect product included Pre-filled Syringe injection (batch no. 3052549) for COVID-19 prophylaxis. No Medical History information was reported. On 01-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 01-Oct-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced SYRINGE ISSUE (more than half of the dose came out as I tried to remove the cap to attach the needle.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse effect). At the time of the report, SYRINGE ISSUE (more than half of the dose came out as I tried to remove the cap to attach the needle.) 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 medication was reported. It was reported an issue with a Moderna Spikevax vaccine syringe, where more than half of the dose was expelled upon attempting to remove the cap to attach the needle. The syringe showed no visible cracks, and the cap remained in place. They were seeking guidance on how to address this issue. The Device Problem Information included FDA code: 1250, IMDRF Code: A050401, Device problem: Fluid Leak. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2025: Live non-significant follow-up information received: Reference ids added.