Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Device issue, No adverse event
Clinical narrative: The plunger component of the syringe was completely stuck. He was unable to push the vaccine through the needle to administer to the patient; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE ISSUE (The plunger component of the syringe was completely stuck. He was unable to push the vaccine through the needle to administer to the patient) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032218) for COVID-19 prophylaxis.    The suspect product included Pre-filled Syringe injection (batch no. 3032218) for COVID-19 prophylaxis.    No Medical History information was reported.   On 01-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (The plunger component of the syringe was completely stuck. He was unable to push the vaccine through the needle to administer to the patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE ISSUE (The plunger component of the syringe was completely stuck. He was unable to push the vaccine through the needle to administer to the patient) 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 assessment was provided for DEVICE ISSUE (The plunger component of the syringe was completely stuck. He was unable to push the vaccine through the needle to administer to the patient).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for DEVICE ISSUE (The plunger component of the syringe was completely stuck. He was unable to push the vaccine through the needle to administer to the patient).    No concomitant medications were provided.  The pharmacist technician was calling about defective dose of Spikevax PFS (with blister pack). Upon administering the dose to the patient on 1Nov2023, the plunger component of the syringe was completely stuck. He was unable to push the vaccine through the needle to administer to the patient. He had to open a new one. The HCP confirmed that he used a different syringe with same lot number (3032218) to administer the dose to the patient. He did not use any of the dose that was in the defective syringe, but he did inject the patient with the needle. He was requesting a replacement for the defective syringe.   The Device problem code for Spikevax syringe include FDA code, agency code which include Defective Device.  The device was malfunctioned, and the malfunction type.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2023: Live Follow up received contains PQC report that includes reference number added.