Received Apr 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | — |
Severe allergic reaction; Initial information received on 26-Mar-2026 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 79-year-old male patient who experienced severe allergic reaction after being treated with trivalent influenza vaccine (FLUZONE HD). The patient's past medical history, past medical treatment(s), past drugs, vaccination(s), family history and concomitant medications were not provided. On an unknown date, the patient started taking trivalent influenza vaccine suspension for injection (dose, formulation, strength, route, lot, expiry and administration site: unknown) for inf Influenza lueza (Influenza immunisation). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. On an unknown date patient had severe allergic reaction (Hypersensitivity) (unknown latency). Pharmacist reported that they have a patient who had a severe allergic reaction to FLUZONE HD vaccine. When they were checking their drug library for drug interaction in their system and when they were trying to order a subcutaneous Heparin for DVT prophylaxis, they were getting an alert for cross reactivity with FLUZONE HD. However, when she was reviewing the package insert, there's no Heparin mentioned in any of the inactive ingredients or excipients. She just wanted to see if during any steps in the process of preparation of the vaccine, Heparin was used or not. She just wants to make sure that it has no Heparin component in the vaccine that would have explained the reaction. Pharmacist then said that it was not clear if it was exactly FLUZONE or FLUZONE HD. She's just assuming it's FLUZONE HD since the patient is elderly. She said that she will not be able to provide the patient information because she's not the one who gave the vaccine to the patient. This happened outpatient, but the patient was hospitalized for a different reason. Action taken was not applicable. Corrective treatment was not reported. Event outcome was unknown for hypersensitivity.
Comments: NONE