Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Device leakage, No adverse event
Clinical narrative: No adverse event; This morning around 9:30 the HCP attached the needle to the syringe and went she punctured the patient the product went out. Also, when she pull it out of his arm the needle fell off. The patient it's feeling good.; This morning around 9:30 the HCP attached the needle to the syringe and went she punctured the patient the product went out. Also, when she pull it out of his arm the needle fell off. The patient it's feeling good.; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE CONNECTION ISSUE (This morning around 9:30 the HCP attached the needle to the syringe and went she punctured the patient the product went out. Also, when she pull it out of his arm the needle fell off. The patient it's feeling good.), DEVICE LEAKAGE (This morning around 9:30 the HCP attached the needle to the syringe and went she punctured the patient the product went out. Also, when she pull it out of his arm the needle fell off. The patient it's feeling good.) and NO ADVERSE EVENT (No adverse event) in a 48-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031633) for COVID-19 prophylaxis.    Suspect product included Pre-filled Syringe injection (batch no. 3031633) for COVID-19 prophylaxis.    Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE.   On 09-Feb-2024, 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 09-Feb-2024, the patient experienced DEVICE CONNECTION ISSUE (This morning around 9:30 the HCP attached the needle to the syringe and went she punctured the patient the product went out. Also, when she pull it out of his arm the needle fell off. The patient it's feeling good.) and DEVICE LEAKAGE (This morning around 9:30 the HCP attached the needle to the syringe and went she punctured the patient the product went out. Also, when she pull it out of his arm the needle fell off. The patient it's feeling good.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE CONNECTION ISSUE (This morning around 9:30 the HCP attached the needle to the syringe and went she punctured the patient the product went out. Also, when she pull it out of his arm the needle fell off. The patient it's feeling good.), DEVICE LEAKAGE (This morning around 9:30 the HCP attached the needle to the syringe and went she punctured the patient the product went out. Also, when she pull it out of his arm the needle fell off. The patient it's feeling good.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were provided. Dosage text for suspect product was reported as unknown.  The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which include Use of Device Problem and FDA code 1250, IMDRF code A050401 which include Fluid Leak. Malfunction type was reported as CIRM.  No treatment medication was provided.