Received Nov 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8874BA | OT / LA |
diagnosed with uvulitis; back of their throat was swollen; had high blood pressure; high heart rate; Initial information received on 06-Nov-2025 regarding an unsolicited valid non-serious case (along with live follow -up attached with csd dated:06-Nov-2025) received from a Patient. This case involves a 67 years old female patient who had diagnosed with uvulitis, high blood pressure and high heart rate after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Nov-2025, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, lot U8874BA, expiry date: 30-Jun-2026, frequency: once, strength high dose, via intramuscular route in the left arm for Influenza [Influenza immunisation]. On 04-Nov-2025 the patient had diagnosed with uvulitis (uvulitis), had high blood pressure (hypertension), back of their throat was swollen (pharyngeal swelling) and high heart rate (heart rate increased) (latency: 2 days). Relevant laboratory test results included: Blood pressure measurement - On 04-Nov-2025: 157/84 UNK [157/84] Heart rate - On 04-Nov-2025: 122 beats/min Action taken was not applicable. Treatment: The patient was treated with Ketorolac tromethamine (Toradol) through the IV for Uvulitis and Pharyngeal swelling, Methylprednisolone sodium succinate (Solu medrol) for Uvulitis and Pharyngeal swelling and when they were discharged, given with Prednisone. It was not reported if the patient received a corrective treatment for the events (high blood pressure and high heart rate). At time of reporting, the outcome was Unknown for all the events.
Test Date: 20251104; Test Name: blood pressure; Result Unstructured Data: 157/84; Test Date: 20251104; Test Name: heart rate; Test Result: 122 {DF}