Received Sep 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT / LA |
had a runny nose; stomach is still a little "upset" but she hasn't done anything; her arm was maroon for a couple of days after the administration; felt like she's had the flu.; has had a decreased appetite; has had a headache in the back and front of her head on and off since she received FLUZONE HD; had a fever, but noted that she has not taken her temperature to confirm fever; chills on and off since the administration; noted "uncontrollable diarrhea" that started the day after she received FLUZONE HD; Initial information received on 09-Sep-2025 regarding an unsolicited valid non-serious case received from a patient. This case involves a 71 years old female patient who had a runny nose, stomach is still a little upset but she hasn't done anything, has had a decreased appetite, has had a headache in the back and front of her head on and off since she received fluzone hd, had a fever, but noted that she has not taken her temperature to confirm fever, chills on and off since the administration, noted uncontrollable diarrhea that started the day , her arm was maroon for a couple of days and felt like she's had the flu after the administration of 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. The patient's past medical history included Sinus disorder. At the time of the event, the patient had ongoing Multiple sclerosis and Hypothyroidism. Patient had also given herself MS (Multiple sclerosis) shots in that arm about 6-7 years ago (capture in history), but she has stopped receiving the MS shots. On 25-Aug-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 number, expiry date and strength not reported) via intramuscular route in the left arm for immunisation. On 25-Aug-2025 the patient had a runny nose (rhinorrhoea), stomach is still a little "upset" but she hasn't done anything (abdominal discomfort), has had a decreased appetite (decreased appetite), had a headache in the back and front of her head on and off since she received fluzone hd (headache), had a fever, but noted that she has not taken her temperature to confirm fever (pyrexia), noted "uncontrollable diarrhea that started the day after she received fluzone hd (diarrhoea), her arm was maroon for a couple of days after the administration (skin discolouration) and felt like she's had the flu (influenza like illness) (latency: same day). Reportedly, She described how she was in bed for a week, has had a decreased appetite and has felt like she's had the flu. Caller is concerned to take FLUZONE HD next time. The patient felt like she had to get the flu shot in order to be around her dad, who is 96 years old. She is 71 years old. Caller also feels like she needs to get the COVID vaccine before seeing her dad, but it was not available at the time she received FLUZONE HD. Caller wasn't sure if she should call her PCP [Primary Care Physician] or MS [Medical Specialist] doctor in regards to her symptoms and to discuss whether she should receive a COVID vaccine. Caller does not want to have the same reaction to the COVID vaccine that she had to FLUZONE HD. Action taken was not applicable. The patient was treated with Loperamide hydrochloride (Imodium) for Diarrhoea and abdominal discomfort. It was not reported if the patient received a corrective treatment for rest of the events. At time of reporting, the outcome was Recovering / Resolving for the Rhinorrhoea was Recovered / Resolved on 28-Aug-2025 for the event Diarrhoea and was Unknown for rest all the events.
Hypothyroidism; MS
Medical History/Concurrent Conditions: Sinus disorder