Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
Stressed; Feeling sick; Infusion site came out twice this month; Initial information received on 26-Sep-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional). This case involves a 65 years old female patient (63 kg) who had stressed, feeling sick and infusion site came out twice this month after receiving Influenza Vaccine and treated with Treprostinil sodium. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Omeprazole, Cetirizine hydrochloride (Zyrtec); Furosemide, Mycophenolate mofetil, Sodium chloride (Saline nasal spray); Paracetamol (Tylenol); Macitentan (Opsumit); Magnesium chelate (Magnesium); Ketamine hydrochloride (Ketamine HCL); Glycine max extract (Lecithin); Apixaban (Eliquis); Fluticasone propionate (Flonase allergy relief); Cod-liver oil (Cod liver oil); Clonidine, Ketoprofen, Ascorbic acid, Biotin, Calcium pantothenate, Cyanocobalamin, Ergocalciferol, Iron, Nicotinamide, Pyridoxine hydrochloride, Retinol, Riboflavin, Thiamine hydrochloride, Tocopheryl acetate (Centrum); Calcium, Oxygen, Montelukast sodium, Lidocaine hydrochloride (Lidocaine HCL); Amitriptyline hydrochloride (Amitriptyline); Gabapentin, Poloxamer and Ondansetron hydrochloride (Ondansetron HCL). On 18-Sep-2025, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, formulation, expiry date and strength not reported) via unknown route in unknown administration site for Flu vaccination (Influenza immunization). On an unknown date, the patient started taking Treprostinil sodium (0.044 µg/kg, formulation and expiry date unknown) subcutaneous for Pulmonary arterial hypertension. Information on the batch number was requested corresponding to the one at time of event occurrence. On an unknown date in Sep-2025, the patient developed stressed (stress), feeling sick (malaise) and infusion site came out twice this month (device dislocation) (latency approximately few days) following intake of Treprostinil sodium and administration of Influenza Vaccine. 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 Unknown for all the events.
Omeprazole; Zyrtec; Furosemide; Mycophenolate mofetil; Saline nasal spray; Tylenol; Opsumit; Magnesium; Ketamine HCL; Lecithin; Eliquis; Flonase allergy relief; Cod liver oil; Clonidine; Ketoprofen; Centrum; Calcium; Oxygen; Montelukast sod