Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U8881AA | OT |
grabbed the FLUZONE out of the fridge, set it down at her keyboard to note lot number, when she picked it up her hand was wet, half of the solution was already on her paperwork, and the plunger came out on the opposite side with no reported ae; grabbed the FLUZONE out of the fridge, set it down at her keyboard to note lot number, when she picked it up her hand was wet, half of the solution was already on her paperwork, and the plunger came out on the opposite side with no reported ae; Initial information received on 26-Sep-2025 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 40 years old female patient who was exposed to Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] when, after retrieving the vaccine from the refrigerator and placing it near her keyboard to record the lot number, she noticed her hand was wet; half of the solution had leaked onto her paperwork, and the plunger had detached from the opposite end with no adverse event was reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Sep-2025, the patient was exposed to an unknown dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (unknown strength) lot U8881AA and expiry date 30-Jun-2026 via unknown route in unknown administration site for influenza when, after retrieving the vaccine from the refrigerator and placing it near her keyboard to record the lot number, she noticed her hand was wet; half of the solution had leaked onto her paperwork, and the plunger had detached from the opposite end with no adverse event (accidental exposure to product) and (exposure via skin contact) (Latency Same day). Reportedly, MA (medical assistant) also mentioned that when she grabbed a different vaccine to administer to a patient, it was fine and only the first vaccine had a problem. Action taken was not applicable. 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.