Received Oct 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052087 | IM |
No adverse effect; they discovered that the syringe had no plunger/a syringe without a plunger in a drop shipment; The HCP called and reported that they tried to administer an mNEXSPIKE 2025-2026 vaccine yesterday; however, they discovered that the syringe had no plunger, which prevented them from administering the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE ISSUE (they discovered that the syringe had no plunger/a syringe without a plunger in a drop shipment), INTERCEPTED PRODUCT ADMINISTRATION ERROR (The HCP called and reported that they tried to administer an mNEXSPIKE 2025-2026 vaccine yesterday; however, they discovered that the syringe had no plunger, which prevented them from administering the vaccine) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052087) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3052087) for COVID-19 prophylaxis. No Medical History information was reported. On 08-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 08-Oct-2025, the patient experienced DEVICE ISSUE (they discovered that the syringe had no plunger/a syringe without a plunger in a drop shipment) and INTERCEPTED PRODUCT ADMINISTRATION ERROR (The HCP called and reported that they tried to administer an mNEXSPIKE 2025-2026 vaccine yesterday; however, they discovered that the syringe had no plunger, which prevented them from administering the vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (they discovered that the syringe had no plunger/a syringe without a plunger in a drop shipment), INTERCEPTED PRODUCT ADMINISTRATION ERROR (The HCP called and reported that they tried to administer an mNEXSPIKE 2025-2026 vaccine yesterday; however, they discovered that the syringe had no plunger, which prevented them from administering the vaccine) 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 provided. The HCP reported that they had attempted to administer the mNEXSPIKE 20252026 COVID-19 vaccine to a patient the previous day but were unable to do so. They explained that the syringe, which had been received was missing a plunger despite having a needle attached. As a result, the vaccine could not be administered. The HCP confirmed that no patient administration had occurred and requested a replacement for the defective syringe. It was unknown if the patient experienced any additional symptoms or events. The Device problem code for pre-filled syringe include FDA code 2306, code A020602 which included Component Missing. Treatment medication was not reported. Most recent FOLLOW-UP information incorporated above includes: On 09-Oct-2025: Live follow-up received and non-significant information includes reference numbers added. On 10-Oct-2025: Live follow-up received and non-significant information includes verbatim updated and reference numbers added.