Received Dec 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Got the flu but it still went to pneumonia; Got the flu; Cold; It usually goes to bronchitis; Serious Infection; This case initially received on 11-Dec-2025 was reported by a non health professional and concerns an adult female patient. Administration of company suspect drug: On an unknown date, the patient received INN Flu Vaccine Seasonal for indication not reported, Dose regimen: Not reported, Route of administration: Not reported, Route of administration: not reported, Lot number: Not reported and would not be obtained due to no follow-up consent. No additional suspect drugs. Adverse reactions/events and outcomes: On 01-Jan-2025, the patient experienced Serious Infection (Medically Significant, outcome: Not Reported). On an unknown date, the patient experienced Got the flu but it still went to pneumonia (Medically Significant, outcome: Not Reported), Got the flu (Medically Significant, outcome: Not Reported), Cold (outcome: Not Reported), It usually goes to bronchitis (outcome: Not Reported). Case was upgraded to serious upon company assessment of the reported event (Serious Infection, Got the flu but it still went to pneumonia, Got the flu) clinical significance. Patient got a serious infection in Jan-2025, nothing ever since. Patient got the flu shot and got the flu but it still went to pneumonia, patient had a few cases (couple of times) when patient gets a cold it usually goes to bronchitis, and in a few days later it goes away, (3 or 4 days). He didn't know what day got the colds. Patient did not take antibiotics and got better. INN Flu Vaccine Seasonal action taken: Not reported Reporter's assessment: The primary reporter did not provide the seriousness and causality for any the event. 23-DEC-2025 (System Update): Linked Case ID(s):2025229830 (Patient Link); Reporter's Comments: Causality: Not related for pneumonia and influenza, considering both the events as coincidental with no biological plausibility for the product to cause/contribute. Related for Infection, bronchitis and nasopharyngitis, considering insufficient information regarding drug event temporality, investigations and treatment details, relevant medical history, and concomitant medications to perform a more in-depth analysis.
Comments: None