Received Sep 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Bronchopneumonia; Immune defenses are lowered; still unwell; This spontaneous case, initially received on 16-Sep-2025, was reported by a non-health professional and concerns a female patient of unknown age. Relevant History and concomitant medication were not reported. Administration of company suspect drug: On an unknown date, the patient received INN Flu Vaccine Seasonal for indication Not reported, Dose regimen: not reported, Anatomical Location: not reported, Route of administration: Unknown, Lot number: No batch number available and unable to obtain due to no follow-up consent provided. Non-company suspect drugs: COVID-19 vaccine (COVID-19 vaccine), Indication: Not reported. Dose regimen: not reported, Anatomical Location: not reported, Route of administration: not reported, Lot number: No batch number available and unable to obtain due to no follow-up consent provided. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Bronchopneumonia (Medically Significant, outcome: Not recovered / Not resolved), Immune defenses are lowered (outcome: Not recovered / Not resolved), On an unknown date, the patient experienced still unwell (outcome: Not recovered / Not resolved). Case was upgraded to serious upon company assessment of the reported event's (Bronchopneumonia) clinical significance. With the vaccine, the immune defences were lowered. To a friend of reporter, after the Covid serum and then the flu vaccine, bronchopneumonia and after six weeks she was still unwell. The reporter had urged others to stop ruining people. INN Flu Vaccine Seasonal action taken: Not Applicable Reporter's assessment: The reporter assessed the event Bronchopneumonia as non-serious and the causality assessment reported as unknown. The reporter did not provide a seriousness or causality assessment for event Immune defenses are lowered, still unwell .; Reporter's Comments: Causality: Due to the spontaneous nature of the case, the events are considered related for reporting purposes. For the events bronchopneumonia, decreased immune responsiveness there is insufficient information about precise event latency, clinical course, type/organism identified, diagnostic reports, treatment taken, medical history to perform a more in-depth analysis. Malaise is likely attributed to bronchopneumonia. Co-suspect Covid19 vaccination is a confounding factor.
Comments: None