Symptomtext
vaccine was running down the patient's arm (with no reported adverse event); vaccine was running down the patient's arm (with no reported adverse event); Initial information received on 17-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 36 years old female patient who was administered the Influenza Quadrival A-B Vaccine[Fluzone QIV] which was running down the patient's arm (with no reported adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Prophylactic vaccination. On 17-Nov-2023, the patient received a 0.5 ml dose of suspect Influenza Quadrival A-B Vaccine (lot U8201BA, expiry date: 30-Jun-2024 with unknown strength) via intramuscular route in the right arm as Immunization. On 17-NOV-2023 while administration of vaccine to the patient the vaccine was running down the patient's arm (with no reported adverse event) (accidental exposure to product) (exposure via skin contact) same day following the administration of Influenza Quadrival A-B Vaccine. It was reported "when the medical assistant was administering the fluzone qiv np pre-filled syringe, it began to leak and the vaccine ran down the medical assistant's gloves and the patient's arm. she believes that there is a crack where you attach the needle to the syringe (at the luer-lock tip) because this is where the leaking was coming from. The medical assistant confirms that the vaccine never got on her own skin, it was only on her glove. They did not notice the crack until they were administering the vaccine and it started leaking out " This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.