Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Consistent coughing; This spontaneous case, initially received on 02-Oct-2025, was reported by a health professional and concerns an elderly patient. At the time of this report, the patient was elderly. Relevant medical history included comorbidities. Concomitant medication was unknown. Administration of company suspect drug: On an unknown date, the patient received Fluad (TIV) for Active immunization for the prevention of influenza disease, Dose regimen: not reported, Route of administration: not reported; Anatomical Location: not reported, Lot number: No batch number available, would be requested upon follow up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Consistent coughing (Medically Significant, outcome: Unknown). An elderly patient with comorbidities was given a dose of Fluad and experienced overnight consistent coughing and ended up in the emergency room. Fluad (TIV) action taken: Not Applicable Reporter's assessment: The primary reporter considered the event Consistent coughing as serious (Medically Significant) and did not provide the causality assessment.; Reporter's Comments: Due to the spontaneous nature of the case, the event is considered related for reporting purposes. Related for the event cough as there is an implied temporal plausibility (was given a dose of Fluad and experienced overnight consistent coughing). However, further information is required regarding relevant medical history, concomitant medications, final diagnosis etc to perform in-depth analysis. However patient's elderly age and underlying medical history of comorbidities could be a confounder for the event.
Comments: Comorbidities