Reporte zur Charge UT8219LA

Symptomtext

guillain-barre syndrome (gbs) after receiving fluzone qiv np; Initial information received on 15-Nov-2023 regarding an unsolicited valid serious case received from a other health professional. This case is linked to case 2023SA360402. This case involves a 45 years old male patient who experienced guillain-barre syndrome (gbs) after receiving influenza quadrival A-B vaccine [Fluzone Quadrivalent]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR); varicella zoster vaccine (Varicella Vaccine); and Hepatitis B Vaccine all for Prophylactic vaccination. On 03-Nov-2023, the patient received a dose 0.5 ml of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot: UT8219LA) (strength; expiry date unknown) via intramuscular route in unknown administration site for Immunization. On an unknown date the patient developed guillain-barre syndrome (gbs) after receiving influenza quadrival A-B vaccine (guillain-barre syndrome) (unknown latency). Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. This event was assessed as medically significant. The patient was hospitalized for this event and was hospitalized on 12-Nov-2023. Additional information was received on 01-Dec-2023. case validity was upgraded to valid case and an event was added (missed to be assessed by previous user). Clinical course updated and text amended accordingly.; Sender's Comments: Sanofi Company Comment dated 01-Dec-2023: This case involves a 45 years old male patient who experienced guillain-barre syndrome (gbs) after receiving influenza quadrival A-B vaccine [Fluzone Quadrivalent]. Further information on allergy history, patient's medical history, family history, past or concomitant medication, laboratory investigation, previous laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.