Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8135DA | OT / LA |
was sweating; said that just 2 minutes after getting the shot, she felt unwell; had chills; Initial information received on 02-Oct-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional). This case involves a 75 years old female patient who was sweating, said that just 2 minutes after getting the shot, she felt unwell and had chills 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 an unknown date in OCT- 2023, the patient received an unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8135DA, frequency once, expiry date and strength not reported) via intramuscular route in the left arm for Influenza (Influenza immunization). On an unknown date in OCT- 2023, the patient was sweating (hyperhidrosis), said that just 2 minutes after getting the shot, she felt unwell (malaise) and had chills (chills) (latency 2 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine. Reportedly, the pharmacy offered to call for an ambulance but she declined as after about 30 minutes: she started feeling well enough to drive her car. She wanted know if others reported the same reaction. She advised that she didn't get her flu shots last year (2024) because of this experience but she was thinking about getting a flu shot this year (2025). Patient mentioned that she had been getting FLUZONE HD every year for 7 years prior to the reaction. Patient also wanted know if there are other flu vaccines for patients less than 65 years old. Patient thought it might have a lesser reaction. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Recovered / Resolved on an unknown date in October 2023 for all the events.