Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8847BA | OT / LA |
feeling horrible and they still are not feeling well yet; extreme fatigue; joint pain, every joint in the body hurts really bad; bad headache; low grade fever; lot of itching of the nose and lips; lot more wheezing more than they usually do with the lung; anxiety; felling disoriented; no appetite; Initial information received on 03-Oct-2025 regarding an unsolicited valid non-serious case received from patient. This case involves a 77 years old female patient who experienced feeling horrible and they still are not feeling well yet, lot more wheezing more than they usually do with the lung, extreme fatigue, anxiety, joint pain, every joint in the body hurts really bad, bad headache, low grade fever, felling disoriented, no appetite and lot of itching of the nose and lips after receiving vaccine 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. At the time of the event, the patient had ongoing Interstitial lung disease. On 20-Aug-2025, the patient received 0.5 ml of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, Suspension for injection in pre-filled syringe (lot U8847BA and expiry 30-Jun-2026) via unknown route in the left arm for immunization (strength: standard). On an unknown date in 2025 the patient developed a non-serious lot more wheezing more than they usually do with the lung (wheezing), extreme fatigue (fatigue), anxiety, joint pain, every joint in the body hurts really bad (arthralgia), bad headache (headache), low grade fever (pyrexia), felling disoriented (disorientation), no appetite (decreased appetite) and lot of itching of the nose and lips (pruritus) (latency unknown). On 21-AUG-2025 the patient developed a non-serious feeling horrible and they still are not feeling well yet (malaise) (latency 1 day). Reportedly:- Patient have extreme fatigue described as all they could do was go back and forth from the bathroom and they could not hold a phone; that since the injection the caller has had anxiety, joint pain, every joint in the body hurts really bad, having a bad headache, having a low grade fever, felling disoriented, and having no appetite; that the consumer still does not have an appetite; that the consumer also having a lot of itching of the nose and lips; that her doctors did nothing for the events; that they saw their primary care doctor and was told to go to the Emergency Room; that while there, at the emergency room, they took blood and the results were okay; that the doctor has called to check up on them; that the doctor thinks the caller may be having a reaction to a different strain in the vaccine; that they did not really want the flu shot, this year, due to hearing what the health secretary was saying about products added in the vaccine; that the Pulmonologist reported that that consumer would be getting a newer FLUZONE HD that does not have this; that she has had flu shots every year and has never had an adverse action at all; that they did take the flu shot last year and ended up getting the flu; and that they do not know the brand or name of the flu vaccine they got last year. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all events At time of reporting, the outcome was Not Recovered / Not Resolved for the events (Malaise and no appetite ) and unknown for rest of the events
Interstitial lung disease