Received Feb 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUCELVAX) | SEQIRUS, INC. | UNK | 946583 | — |
Guillain-Barre Syndrome; Facial paralysis is still pretty significant.; Patient still can't walk without walker; Syncope; Presyncope; Paresthesia; This spontaneous case, initially received on 20-Feb-2025, was reported by a health professional and concerns an adult male patient. Concomitant medication were reported as unknown and patient has no medical history. There was no allergy information reported. There was no product complaint associated with this case. Administration of company suspect drug: On 01-Jan-2025, the patient received Flucelvax (TIV) for Indication not reported, Dose regimen: 0.5 ml, Route of administration: not reported, Anatomical location: not reported, Lot number: 946583. No additional suspect drugs. Adverse reactions/events and outcomes: On 14-Feb-2025, the patient experienced Guillain-Barre Syndrome (Medically Significant, Hospitalized, outcome: Not recovered / Not resolved), Facial paralysis is still pretty significant (Medically Significant, Hospitalized, outcome: Not recovered / Not resolved), Patient still can't walk without walker (Hospitalized, outcome: Not recovered / Not resolved). On an unknown date, the patient experienced Syncope (Medically Significant, outcome: Not Reported), presyncope (outcome: Not Reported), paresthesia (outcome: Not Reported). The following additional adverse events had been identified during post-approval use of FLUCELVAX or FLUCELVAX QUADRIVALENT. Because these events were reported voluntarily from a population of uncertain size, it was not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine. Nervous systems disorders: Syncope, presyncope, paresthesia, Guillain-Barré syndrome." Patient received Flucelvax and experienced Guillain-Barré Syndrome. Patient still could not walk without walker and facial paralysis was still pretty significant. Patient never experienced an adverse reaction to the vaccine. It was prescribed to patient 5 days of hemoglobulin therapy infusion. Flucelvax (TIV) action taken: Not Applicable Treatment medication: Hemoglobin Reporter's assessment: The reporter assessed the events Guillain-Barre Syndrome, Facial paralysis is still pretty significant, and Patient still can't walk without walker as serious (Hospitalization) and did not provide the causality assessment. The reporter did not provide the seriousness and causality assessment for the rest of the events.; Reporter's Comments: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Causal association could not be completely ruled out in view of insufficient information, hence causality assessed as related.(onset latency/temporality, medical history, concomitant drugs,diagnostic reports). Brighton collaboration criteria assessed as Level 4 (insufficient information to meet any level of certainty) for Guillain Barre Syndrome and facial paralysis .
Comments: None