Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, No adverse event, Product leakage
Clinical narrative: vaccine solution was coming out from that connection (between needle and syringe) rather than going into the patient's arm; There appeared to be a little bit of moisture (nurse thinks it was vaccine liquid) where the needle and the syringe connected; No adverse effect; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE CONNECTION ISSUE (vaccine solution was coming out from that connection (between needle and syringe) rather than going into the patient's arm), PRODUCT LEAKAGE (There appeared to be a little bit of moisture (nurse thinks it was vaccine liquid) where the needle and the syringe connected) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043029) for COVID-19 prophylaxis.    The suspect product included Pre-filled Syringe injection (batch no. 3043029) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (vaccine solution was coming out from that connection (between needle and syringe) rather than going into the patient's arm), PRODUCT LEAKAGE (There appeared to be a little bit of moisture (nurse thinks it was vaccine liquid) where the needle and the syringe connected) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE CONNECTION ISSUE (vaccine solution was coming out from that connection (between needle and syringe) rather than going into the patient's arm), PRODUCT LEAKAGE (There appeared to be a little bit of moisture (nurse thinks it was vaccine liquid) where the needle and the syringe connected) and NO ADVERSE EVENT (No adverse effect) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   No concomitant medication was reported.  HCP called to report a product complaint for a syringe they used on 09-Oct-2024. When the needle was screwed onto the prefilled syringe, the nurse doing so indicated that it just did not quite feel right. There appeared to be a little bit of moisture (nurse thought it was vaccine liquid) where the needle and the syringe connected. The nurse tightened that connection a bit more to make sure that it was engaged correctly. However, when she went to inject the vaccine into the patient's arm, as she pushed the plunger the vaccine solution was coming out from that connection (between needle and syringe) rather than going into the patient's arm. Dose was then repeated with a new syringe with no issues.  Other prefilled syringes from the same carton were administered to patients and they were fine. Syringe was not available to return, as it was disposed of in a sharps container since it had been attempted to be administered to a patient.  The Device problem code for Spikevax syringe include FDA code, agency code which included Connection Problem and Fluid Leak.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Oct-2024: Live Non-Significant Follow-Up information received contains reference ID added.