Sex: U
Vaccine: UNK
Symptoms: Accidental exposure to product, No adverse event, Occupational exposure to product, Syringe issue
Clinical narrative: No adverse event; it squirted out from the side of the barrel of the syringe and nothing came out from the needle. HCP described it as a "hole along the side of the barrel of the syringe; vaccine squirted onto the pharmacist's face and onto the patient's as well (unspecified body part); vaccine squirted onto the pharmacist's face and onto the patient's,; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE MALFUNCTION (it squirted out from the side of the barrel of the syringe and nothing came out from the needle. HCP described it as a "hole along the side of the barrel of the syringe), EXPOSURE VIA SKIN CONTACT (vaccine squirted onto the pharmacist's face and onto the patient's as well (unspecified body part)), ACCIDENTAL EXPOSURE TO PRODUCT (vaccine squirted onto the pharmacist's face and onto the patient's,) 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. 3031281) for COVID-19 prophylaxis.    Suspect product included Pre-filled Syringe injection (batch no. 3031281) for COVID-19 prophylaxis.    No Medical History information was reported.   On 18-Oct-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 18-Oct-2023, the patient experienced DEVICE MALFUNCTION (it squirted out from the side of the barrel of the syringe and nothing came out from the needle. HCP described it as a "hole along the side of the barrel of the syringe), EXPOSURE VIA SKIN CONTACT (vaccine squirted onto the pharmacist's face and onto the patient's as well (unspecified body part)) and ACCIDENTAL EXPOSURE TO PRODUCT (vaccine squirted onto the pharmacist's face and onto the patient's,). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE MALFUNCTION (it squirted out from the side of the barrel of the syringe and nothing came out from the needle. HCP described it as a "hole along the side of the barrel of the syringe), EXPOSURE VIA SKIN CONTACT (vaccine squirted onto the pharmacist's face and onto the patient's as well (unspecified body part)), ACCIDENTAL EXPOSURE TO PRODUCT (vaccine squirted onto the pharmacist's face and onto the patient's,) 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 DEVICE MALFUNCTION (it squirted out from the side of the barrel of the syringe and nothing came out from the needle. HCP described it as a "hole along the side of the barrel of the syringe), EXPOSURE VIA SKIN CONTACT (vaccine squirted onto the pharmacist's face and onto the patient's as well (unspecified body part)) and ACCIDENTAL EXPOSURE TO PRODUCT (vaccine squirted onto the pharmacist's face and onto the patient's,).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for DEVICE MALFUNCTION (it squirted out from the side of the barrel of the syringe and nothing came out from the needle. HCP described it as a "hole along the side of the barrel of the syringe), EXPOSURE VIA SKIN CONTACT (vaccine squirted onto the pharmacist's face and onto the patient's as well (unspecified body part)) and ACCIDENTAL EXPOSURE TO PRODUCT (vaccine squirted onto the pharmacist's face and onto the patient's,).    Pharmacist had called because they want to return a defective PFS (NDC 80777-102-93). They said that while they were administering the vaccine, it squirted out from the side of the barrel of the syringe and nothing came out from the needle.  HCP described it as a "hole along the side of the barrel of the syringe'. The vaccine squirted onto the pharmacist's face and onto the patient's as well (unspecified body part).  HCP declined to provide additional AE information as he stated that does not had anything to do with the patient.  When HCP was injecting the vaccine, the vaccine came out from the barrel of the syringe perpendicular to the direction of the injection.  No vaccine was adminstered to the patient. The Device problem code for Spikevax syringe include codes which include Defective Device. The Spikevax syringe device was malfunctioned and the type was. Concomitant medications were not reported.  No treatment information was provided by the reporter.  This case was considered for the patient whom the vaccine was trying to administered.   This case was linked to US-MODERNATX, INC.-MOD-2023-746631.   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2023: Live follow-up received include suspect product administration date added, narrative updated. On 18-Oct-2023: Live follow-up PQC report received include narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746631: