Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | — |
the caps were very tight and required a lot of force to open, and we ended up losing them; No adverse effect; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT CLOSURE REMOVAL DIFFICULT (the caps were very tight and required a lot of force to open, and we ended up losing them) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT CLOSURE REMOVAL DIFFICULT (the caps were very tight and required a lot of force to open, and we ended up losing them) and NO ADVERSE EVENT (No adverse effect). At the time of the report, PRODUCT CLOSURE REMOVAL DIFFICULT (the caps were very tight and required a lot of force to open, and we ended up losing them) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. For mRNA-1283 (MNEXSPIKE PFS) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. Concomitant medications were not reported. It was reported that there was one little issue that the reporter was trying to troubleshoot. It was basically that the reporter had difficulty with two vaccine doses where the caps were very tight and required a lot of force to open and ended up losing them. Reporter was trying to replace two doses, but though they came in boxes of 10¦. Reporter was asking about any suggestions for how they can replace those vaccines. Treatment information was not reported.