Received Apr 1, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3053756 | IM |
pulled out the stopper on one of the vaccine and there was glass on the tip of the vaccine; syringes were left unused due to an issue; No adverse effect; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE ISSUE (pulled out the stopper on one of the vaccine and there was glass on the tip of the vaccine), INTERCEPTED PRODUCT ADMINISTRATION ERROR (syringes were left unused due to an issue) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3053756) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3053756) for COVID-19 prophylaxis. Medical History (vaccines within the past 4 weeks, medical conditions) was reported as unknown. On an unknown date, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (pulled out the stopper on one of the vaccine and there was glass on the tip of the vaccine), INTERCEPTED PRODUCT ADMINISTRATION ERROR (syringes were left unused due to an issue) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (pulled out the stopper on one of the vaccine and there was glass on the tip of the vaccine), INTERCEPTED PRODUCT ADMINISTRATION ERROR (syringes were left unused due to an issue) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. For mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. Concomitant medication was not reported. It was reported that, pharmacy received the box of vaccine. HCP pulled out the stopper of one of the vaccines and noticed there was glass on the tip of the vaccine. HCP confirmed that the product was purchased directly from Moderna and the product had not been administered to any patient and was still there with them. HCP wanted to return the product and requested a credit, explaining that 3 syringes were left unused due to an issue. Also, mentioned that she had previously communicated with the Quality department, including sending an email with photos of the issue. The Device problem code for pre-filled syringe also included FDA code 1670, IMDRF code A23 which included Use of Device Problem. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. Information received on 22-Mar-2026, 23-Mar-2026 and 24-Mar-2026 has been processed together in the same case cycle. Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2026: Live follow-up received and non-significant information includes reference numbers added. On 24-Mar-2026: Live follow-up received and non-significant information includes narrative updated and reference numbers added.