Received Dec 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | ut8804ba | IM / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | 1 | UT8804BA | OT / LA |
due to the administration of fluzone hd to a patient under 65 years of age with no adverse event; Initial information received on 18-Dec-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 31 years old female patient who was administered to Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd], with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) and Tozinameran (Pfizer BioNTech COVID-19 vaccine) for Immunisation. On 17-Dec-2025, the patient received 0.5mL (dose 1) of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot UT8804BA, expiry date 30-Jun-2026, frequency once and strength Fluzone High) via intramuscular route in the left arm for Immunisation, with no adverse event (product administered to patient of inappropriate age) (latency same day). It was reported "administration of Fluzone HD to a patient under 65 years of age. Pharmacist sought guidance following the administration of Fluzone HD to a 31-year-old patient. They specifically asked what they should look out for?" 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.
Heplisav b; Pfizer BioNTech COVID-19 vaccine