Reporte zur Charge UT7315M

Symptomtext

she was diagnosed with Guillain-Barre syndrome post vaccination; she had a facial droop; Patient started having right toe numbness. The right toe then spread to her hands; Initial information received on 01-Apr-2022 regarding an unsolicited valid serious case received via other health professional. This case involves an unknown age female patient who experienced she was diagnosed with guillain-barre syndrome post vaccination, patient started having right toe numbness. the right toe then spread to her hands and she had a facial droop after receiving vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Menactra) and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 28-Feb-2022, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (dose, route, lot number and administration site: unknown) for Prophylactic vaccination. It was reported that the employee was vaccinated on 28-Feb-2022. All vaccines were work related, Menactra, Fluozne Quiv, and Adacel. On 14-Mar-2022 the employee started having right toe numbness and the right toe then spread to her hands (hypoaesthesia) (latency: 17 days) and on 20-Mar-2022 noticed she had a facial droop (facial paralysis) (latency: 23 days) and she was admitted to the hospital 20-Mar to 26-Mar where she was diagnosed with Guillain-Barre syndrome post vaccination (guillain-barre syndrome) (event onset and latency: unknown). Action taken: not applicable. It was not reported if the patient received a corrective treatment for the events (Patient started having right toe numbness. The right toe then spread to her hands, she had a facial droop, she was diagnosed with Guillain-Barre syndrome post vaccination). At time of reporting, the outcome was Unknown for the events patient started having right toe numbness. the right toe then spread to her hands, she had a facial droop, and she was diagnosed with guillain-barre syndrome post vaccination. Seriousness criteria: Medically significant for the events she was diagnosed with Guillain-Barre syndrome post vaccination and she had a facial droop and hospitalization for the event she was diagnosed with Guillain-Barre syndrome post vaccination.; Sender's Comments: Sanofi Company Comment dated on 07-Apr-2022: This case involves an unknown age female patient who experienced she was diagnosed with guillain-barre syndrome post vaccination, and she had a facial droop after receiving vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Menactra) and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel). The time to onset is compatible with the role of the product for she had a facial droop and not known for the other serious event. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed for complete assessment of the case. Based upon the reported information, the individual role of the suspect vaccine cannot be assessed.