Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
breathing difficulty/ as the day progressed/ got worse; has asthma, that was exacerbated by a recent flu shot; Initial information received on 22-Jul-2025 regarding an unsolicited valid serious case received from a consumer/non-healthcare profesisonal. This case was linked to other case US-SA-2025SA214057 (Dupixent case) This case involves a 77 years old male patient (65.45 kg) who had breathing difficulty/ as the day progressed/ got worse and has asthma, that was exacerbated by a recent flu shot after receiving vaccine influenza vaccine. 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 Asthma. Concomitant medications included calcium; vitamin D3; chondroitin sulfate sodium, glucosamine hydrochloride, manganese gluconate, sodium borate decahydrate (glucosamine & chondoritin); and fish oil. On an unknown date, the patient received unknown dose of suspect influenza vaccine (Unknown strength, formulation, lot and expiry date) produced by unknown manufacturer via unknown route in unknown administration site for prophylactic vaccination (Immunisation) Information on the batch number was requested corresponding to the one at time of event occurrence On 21-Jul-2025 the patient developed breathing difficulty/ as the day progressed/ got worse (dyspnoea) (unknown latency) following the administration of influenza vaccine. On an unknown date the patient developed has asthma, that was exacerbated by a recent flu shot (asthma) (unknown latency) following the administration of influenza vaccine. Reportedly, the patient was hospitalized, due to severe breathing difficulty yesterday morning. As the day progressed, he got worse and went to er at 10pm. He was admitted at around 2am, after he was given 3 breathing treatments. He has asthma, that was exacerbated by a recent flu shot. The patient was started on steroid and is breathing better now. Action taken was not applicable. Patient received 3 breathing treatments and steroid for the events. At the time of reporting, the outcome was Recovering / Resolving for both the events. Seriousness criteria: The patient was hospitalized for this event (Dyspnoea). from JUL-2025; Sender's Comments: Sanofi company comment dated 25-JUL-2025: This case involves a 77 years old male patient (65.45 kg) who had breathing difficulty/ as the day progressed/ got worse and has asthma, that was exacerbated by a recent flu shot after receiving vaccine influenza vaccine. Further information regarding allergic history and tolerance, laboratory investigations excluding alternative etiologies, hospitalization details for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. The patient has a history of asthma that might play confounding role in the occurrence of dyspnea. US-SA-2025SA214057:Dupixent case
Asthma
CALCIUM; VITAMIN D3; GLUCOSAMINE & CHONDORITIN; FISH OIL