Sex: F
Vaccine: FLUX
Symptoms: Nervous system disorder, Ocular discomfort, Optic nerve disorder, Swelling
Clinical narrative: sickness; Difficult to breath; Increased pressure behind eyes; Obturator nerve swollen; Left eye optic nerve problem; Low blood pressure; Headache; Initial information was received on 09-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient (101.8 kg) who experienced sickness, difficult to breath, increased pressure behind eyes, low blood pressure, obturator nerve swollen, left eye optic nerve problem and headache after receiving influenza vaccine and while treated with selexipag, macitentan, digoxin, acetazolamide and furosemide [Lasix].  The patient's past medical history included Pulmonary arterial hypertension. The patient's past medical treatment(s) and family history were not provided.  Concomitant medications included riociguat (Adempas).  On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (unknown formulation) (lot number, expiry date, strength, frequency was unknown) via unknown route in unknown administration site for flu vaccination.  On an unknown date, the patient started taking selexipag Tablet 3200 ug (1 time every 0.5 day) of unknown strength via oral route (with lot - 124898402, 31-Aug-2023) for Pulmonary arterial hypertension.  On an unknown date, the patient started taking macitentan Tablet of unknown dosage, strength and frequency via oral route (with an unknown batch number and expiration date) for Pulmonary arterial hypertension.  On an unknown date, the patient started taking digoxin Tablet 100 mg once daily (QD) of unknown strength via oral route (with an unknown batch number and expiration date) for Product used for unknown indication. On an unknown date, dosage was changed to 300 mg once daily (QD).  On an unknown date, the patient started taking acetazolamide for Optic nerve disorder and lasix (furosemide) for Product used for unknown indication (form, strength, dose, frequency, route, lot number, expiration date, indication: unknown).  On an unknown date the patient developed a non-serious events sickness (illness),  difficult to breath (dyspnoea), increased pressure behind eyes (intraocular pressure increased), low blood pressure (hypotension), obturator nerve swollen (nervous system disorder), left eye optic nerve problem (optic nerve disorder) and headache (unknown latency) following the first and last dose intake of selexipag, macitentan, digoxin, acetazolamide, furosemide and influenza vaccine.  Relevant laboratory test results included: Blood pressure measurement - On an unknown date:  [96/71]; on an unknown date:  [94/76 mmHG]  Action taken with influenza vaccine was not applicable and with selexipag, macitentan, digoxin, acetazolamide and furosemide was unknown.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events sickness, difficult to breath, increased pressure behind eyes, obturator nerve swollen, eye optic nerve problem, was Recovered / Resolved on an unknown date for the event low blood pressure, and headache.