Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product container issue, Syringe issue
Clinical narrative: No adverse event; the nurse was preparing the needle after twisting it, while putting the needle of the hub, the glass of the PFS broke; when the nurse was preparing the needle after twisting it, while putting the needle of the hub, the glass of the PFS broke; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT CONTAINER ISSUE (the nurse was preparing the needle after twisting it, while putting the needle of the hub, the glass of the PFS broke), SYRINGE ISSUE (when the nurse was preparing the needle after twisting it, while putting the needle of the hub, the glass of the PFS broke) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 202623-2a) for COVID-19 prophylaxis.    The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On 06-Nov-2023 at 11:15 AM, the patient experienced PRODUCT CONTAINER ISSUE (the nurse was preparing the needle after twisting it, while putting the needle of the hub, the glass of the PFS broke) and SYRINGE ISSUE (when the nurse was preparing the needle after twisting it, while putting the needle of the hub, the glass of the PFS broke). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT CONTAINER ISSUE (the nurse was preparing the needle after twisting it, while putting the needle of the hub, the glass of the PFS broke), SYRINGE ISSUE (when the nurse was preparing the needle after twisting it, while putting the needle of the hub, the glass of the PFS broke) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT CONTAINER ISSUE (the nurse was preparing the needle after twisting it, while putting the needle of the hub, the glass of the PFS broke) and SYRINGE ISSUE (when the nurse was preparing the needle after twisting it, while putting the needle of the hub, the glass of the PFS broke).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT CONTAINER ISSUE (the nurse was preparing the needle after twisting it, while putting the needle of the hub, the glass of the PFS broke) and SYRINGE ISSUE (when the nurse was preparing the needle after twisting it, while putting the needle of the hub, the glass of the PFS broke).    Concomitant product use was not provided by the reporter. Treatment information was not provided.  The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which include Use of Device Problem. The Spikevax syringe device was malfunctioned and the type was CIRM.   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2023: Significant live follow-up received on 06-Nov-23: Reference numbers added