Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Guillain-Barre syndrome, Loss of personal independence in daily activities, Paralysis
Clinical narrative: couldn't walk, dress or bathe myself; Guillain Barre Syndrome; paralyzed from the neck down; couldn't walk; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2024SA326574 (Sanofi), AE-017009 (BioNTech).  Initial information received on 04Nov2024 regarding an unsolicited valid serious Courtesy case received consumer/non-healthcare professional. This case involves an unknown age male patient who had Guillain barre syndrome and paralyzed from the neck down receiving vaccines tozinameran (Comirnaty) and influenza USP trival A-B high dose subvirion vaccine (Fluzone high dose). The past medical history, medical treatment(s), vaccination(s) and history were not provided. At the lime or the event, patient had ongoing systemic lupus erythematosus in Jun2005. Concomitant medications included hydroxychloroquine for systemic lupus erythematosus; atorvastatin for cardiac disorder; mirabegron (myrbetriq) hypertonic bladder, prednisone for systemic lupus erythematosus; and losartan for renal disorder. On 30Aug2024, the patient received unknown dose of suspect influenza USP trival A-B high dose sub virion vaccine suspension for injection in pre-filled (Unknown strength, and expiry date) via intramuscular route in the right deltoid and unknown dose of tozinameran (Unknown strength, formulation, lot and expiry date) not produced by (name withheld) via intramuscular route in the left shoulder both for prophylactic vaccination (immunization). On an unknown date the patient couldn't walk (gait inability) and couldn't walk, dress or bathe myself (Loss of personal independence in daily activities) (unknown latency) following the administration of influenza USP trival A-B high dose sub virion vaccine and tozinameran. On 03Sep2024 the patient developed Guillain Barre Syndrome and paralyzed from the neck down (paralysis) (Latency 4 days) following the administration of influenza USP trival A-B high dose sub virion vaccine and tozinameran. Information on the batch number was cannot be requested corresponding to the one at time of event occurrence. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was unknown for the events. Seriousness criteria: These events were assessed as medically significant and was leading to disability. The patient was hospitalized for this event during 11 days. From 2024 (hospitalization during 11 days).  BIONTECH SE comment: dated 13Nov2024: This case involves an unknown age male patient who had Guillain Barre Syndrome and paralyzed from the neck down after receiving Vaccines tozinameran (Comitnaty) and influenza USP trival A-B dose subvirion vaccine [fluzone high dos]. Further information regarding allergic history and tolerance, 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 suspect vaccine cannot be assessed.  BIONTECH SE assessment: Case serious: Yes. Company agent causal: Yes. Case listed ness: Unlisted. Case outcome: Unknown.  COMIRNATY (2024-2025 FORMULA) is under agreement with BIONTECH SE.