Received May 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Guillain-Barre Syndrome; This spontaneous case, initially received on 28-May-2025, was reported by a non health professional and concerns an adult female patient. Relevant History and concomitant medication were reported as unknown. Administration of company suspect drug: On an unknown date, the patient received Flucelvax (TIV) for influenza prophylaxis, Dose regimen: not reported, Route of administration: not reported, Anatomical location: not reported, Lot number: Not reported and requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Guillain-Barre Syndrome (Medically Significant, outcome: Recovering/resolving). Case was upgraded to serious upon company assessment of the reported event's clinical significance. An adverse event related to the administration of Flucelvax was reported. Physician informed that one of his patients had experienced an adverse event after receiving the vaccine. The patient was an adult female who developed Guillain-Barré Syndrome following her vaccination with Flucelvax. Doctor recognized the adverse event promptly and provided the necessary care, which improved the patient's outcome Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter considered the causality and seriousness of the event Guillain-Barre Syndrome as unknown; Reporter's Comments: Causality: Due to the spontaneous nature of the case, the event is considered related for reporting purposes. Related considering biological plausibility, however there is insufficient information about precise event latency, therapy details, clinical course, medical history and concomitant medication which precludes a sound medical assessment. According to the Brighton Collaboration criteria, the case meets Level 4 diagnostic certainty for the event of Guillain-Barre Syndrome (there is lack of sufficient information to meet any level of case diagnostic criteria)
Comments: None