Received Nov 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUBLOK) | SANOFI PASTEUR | UNK | U8864AA | OT / LA |
patient was inadvertently administered the Flublok vaccine in the left arm via the subcutaneous route, rather than the recommended intramuscular route,with no reported adverse event; Initial information received on 21-Nov-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 62 years old male patient who was inadvertently administered with Influenza Trivalent Recombinant Vaccine [Flublok] in the left arm via the subcutaneous route, rather than the recommended intramuscular route, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines were given. On 19-Nov-2025, the patient received 0.5 ml dose of suspect Influenza Trivalent Recombinant Vaccine, Solution for injection, lot U8864AA, expiry date: 30-Jun-2026, strength not reported, frequency:once, via subcutaneous route in the left arm for Immunization inadvertently via the subcutaneous route, rather than the recommended intramuscular route, with no reported adverse event (incorrect route of product administration) (latency: same day). 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.