Symptomtext
a lot of the medication was leaked out from the sides of the needle resulting in an under dose,as an occupational/accidental exposure with no reported adverse event; Initial information (received on 19-Sep-2022 processed as non-case) with additional information 19-Sep-2022 regarding an unsolicited valid non-serious case received from a pharmacist. Agency number: 01284280. This case involves a 63-year-old and unknown gender patient who experienced a lot of the medication was leaked out from the sides of the needle resulting in an under dose, as an occupational/accidental exposure with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [FLUZONE]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Sep-2022, the patient received suspect FLUZONE QIV NP at dose 0.5ml once via intramuscular route in the left deltoid (lot: UT7701MA, expiry date: 30-Aug-2022) for Influenza immunization. The patient used the product first time. On 17-SEP-2022, the patient developed a non-serious a lot of the medication was leaked out from the sides of the needle resulting in an under dose, as an occupational/accidental exposure with no reported adverse event (accidental exposure to product) at same day latency. Pharmacist calling to inquire about a FLUZONE QIV NP, a patient was receiving vaccination on 17Sep2022, the needle they used was damaged and a lot of the medication was leaked out from the sides of the needle resulting in an under dose. They are seeking guidance on how to handle this situation. This situation is reported as an occupational/accidental exposure. Action taken: Not applicable. The patient was still using product. At time of reporting, the outcome was Unknown. 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.