Received Nov 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052087 | IM |
No adverse event; When I was pushing the plunger, the vaccine leaked out of the joint between the needle and syringe; administer another mnexspike vaccination to the patient.; This spontaneous case was reported by a pharmacist and describes the occurrence of SYRINGE ISSUE (When I was pushing the plunger, the vaccine leaked out of the joint between the needle and syringe), EXTRA DOSE ADMINISTERED (administer another mnexspike vaccination to the patient.) and NO ADVERSE EVENT (No adverse event) in an 86-year-old male patient 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 23-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 23-Oct-2025, the patient experienced SYRINGE ISSUE (When I was pushing the plunger, the vaccine leaked out of the joint between the needle and syringe) and EXTRA DOSE ADMINISTERED (administer another mnexspike vaccination to the patient.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, SYRINGE ISSUE (When I was pushing the plunger, the vaccine leaked out of the joint between the needle and syringe), EXTRA DOSE ADMINISTERED (administer another mnexspike vaccination to the patient.) and NO ADVERSE EVENT (No adverse event) 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. It was reported that, during the administration of a mnexspike vaccine dose, a significant amount of the vaccine had leaked from the joint between the needle and the syringe while pushing the plunger. It was observed that the majority of the dose appeared to be lost due to this leakage. After a phone conversation with a relevant support team, the healthcare professional had proceeded to administer another mnexspike vaccine to the patient, based on the guidance received. The support team had later forwarded the email sent by the healthcare professional and had requested a credit, suggesting that the issue might have been caused by a fault in the plastic component or the pre-filled syringe. Needle Type: Easy Point needle, Lot Number: K153A, Expiration Date: 03/28/2030 The Device problem code for pre-filled syringe include FDA code 1670, code A23 which included Use of Device Problem. The Device problem code for pre-filled syringe include FDA code 1250, code A050401 which included Fluid Leak. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. Most recent FOLLOW-UP information incorporated above includes: On 23-Oct-2025: Upon internal review on 24-Oct-2025, it was identified that the case MOD-2025-790555 (US-MODERNATX-MOC20251024000019) was created inadvertently as an initial case instead of adding follow up to the already existing case MOD-2025-790551. Hence, all the information from the case MOD-2025-790555 (US-MODERNATX-MOC20251024000019) has been added and merged into the retained case MOD-2025-790551 as a follow-up. The case MOD-2025-790555 (US-MODERNATX-MOC20251024000019) will be deleted from the safety database. Live non-significant follow-up received: Reference ids added. On 28-Oct-2025: Live follow-up received contains No New Information.