Received Jan 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3053856 | IM |
some syringes are leaking from the sides when the needle is screwed on properly; leaked product on the HCP who was handling the administration of it to the patient; No adverse effect; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE CONNECTION ISSUE (some syringes are leaking from the sides when the needle is screwed on properly), OCCUPATIONAL EXPOSURE TO PRODUCT (leaked product on the HCP who was handling the administration of it to the patient) 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. 3053856) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3053856) 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) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (some syringes are leaking from the sides when the needle is screwed on properly), OCCUPATIONAL EXPOSURE TO PRODUCT (leaked product on the HCP who was handling the administration of it to the patient) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE CONNECTION ISSUE (some syringes are leaking from the sides when the needle is screwed on properly), OCCUPATIONAL EXPOSURE TO PRODUCT (leaked product on the HCP who was handling the administration of it to the patient) 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 provided by the reporter. HCP reported an issue with a defective syringe, noting that some syringes were leaking from the sides when the needle was screwed on properly. The problem arose, when pressure was applied to the syringe, and it caused leakage from the side. The Device problem code for pre-filled syringes includes FDA code, code A12 which included Connection Problem. It was unknown if the patient experienced any additional symptoms/events. No treatment medications provided by the reporter.