Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
Fatigue; cough; Facial swelling; Sickness; Initial information received on 11-Mar-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 23 years old male patient who had fatigue, sickness, cough and facial swelling after receiving influenza vaccine and corticotropin. 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 Nephrotic syndrome. Concomitant medications included atorvastatin calcium, furosemide, magnesium oxide; mycophenolate mofetil, olmesartan medoxomil , potassium chloride, prednisone, spironolactone, tacrolimus, ergocalciferol (vitamin d) and omeprazole, all for Product used for unknown indication. 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 vaccine (Immunisation) and cortrophin Gel for injection of strength 1 ml 80 iU (International unit) BIW (twice a week) with lot number 307823 and expiry date 30-Jun-2025 subcutaneous for Nephrotic syndrome. On an unknown date the patient developed a non-serious fatigue, cough and facial swelling (swelling face) (unknown latency) On 28-Oct-2024 the patient developed a non-serious sickness (illness) (unknown latency). Information on the batch number was requested corresponding to the one at time of event occurrence corticotropin (cortrophin) was continued. 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 the event fatigue, was Recovered / Resolved on an unknown date for the event cough, was Recovering / Resolving for the event sickness and was Not Recovered / Not Resolved for the event facial swelling.
Nephrotic syndrome
ATORVASTATIN CALCIUM; FUROSEMIDE; MAGNESIUM OXIDE; MYCOPHENOLATE MOFETIL; OLMESARTAN MEDOXOMIL; POTASSIUM CHLORIDE; PREDNISONE; SPIRONOLACTONE; TACROLIMUS; VITAMIN D [ERGOCALCIFEROL]; OMEPRAZOLE; CORTROPHIN