Received Feb 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUBLOK) | SANOFI PASTEUR | UNK | U8790AA | OT / LA |
inadvertently administered to a 7-year-old patient; there was redness area on the arm at the injection site; there was swelling area on the arm at the injection site; patient was complaining of pain; Initial information received on 18-Feb-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case reports influenza trivalent recombinant vaccine [Flublok] was inadvertently administered to a 7-year-old male patient who experienced redness area on the arm at the injection site, swelling area on the arm at the injection site and patient was complaining of pain. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 11-Feb-2026, the 7-year-old patient was inadvertently administered 0.5 ml dose of influenza trivalent recombinant vaccine, Solution for injection (lot U8790A; expiry date: 30-Apr-2026) via unknown route (reported as Arm) in the left deltoid for Immunization (product administered to patient of inappropriate age) (latency: same day) On unknown date in FEB-2026 the patient's parent reported there was redness area on the arm at the injection site (vaccination site erythema), there was swelling area on the arm at the injection site (vaccination site swelling) and patient was complaining of pain (pain) (approximately few days latency). it was reported that "practice administrator was asked if that's a common side effect; But symptoms has already subsided and everything was fine from the last follow up from the dad and no further treatment was done." Action taken: Not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was was Recovered / Resolved on an unknown date for the events. 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.