Received Oct 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052553 | IM |
HCP had a damaged/broken vaccine; tip of the syringe was yellowish or is having some kind of discoloration; No adverse effect; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE BREAKAGE (HCP had a damaged/broken vaccine), DEVICE COLOUR ISSUE (tip of the syringe was yellowish or is having some kind of discoloration) 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. 3052553) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3052553) 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) .25 milliliter and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE BREAKAGE (HCP had a damaged/broken vaccine), DEVICE COLOUR ISSUE (tip of the syringe was yellowish or is having some kind of discoloration) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE BREAKAGE (HCP had a damaged/broken vaccine), DEVICE COLOUR ISSUE (tip of the syringe was yellowish or is having some kind of discoloration) 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 provided. It was reported that the HCP had a damaged/broken vaccine and the tip of the syringe was yellowish or was having some kind of discoloration. HCP was asking if they can get a replacement or credit for that. It was unknown if the patient experienced any additional symptoms/events. The Device Problem Information included FDA code: 2284, Code: A0204, Device problem: Device Damaged Prior to Use and FDA code: 1170, Code: A0407, Device problem: Material Discolored. No treatment medication was provided.