Age: 16.0
Sex: F
Vaccine: FLUX, MEN
Symptoms: Headache, Immediate post-injection reaction, Mydriasis, Photophobia, Sensory overload
Clinical narrative: sensory overload; dizziness; teeth chattering; enlarged pupils; started having vision sensitivity to light; depth perception; child was difficult to awake her eyes were open, but she was not there; it shook her brain like a train went through it; child slumped over onto the nurse right after the injections; complained of a headache/increased headache; Initial information received regarding an unsolicited valid  serious case received from a consumer/non-hcp.  This case involves a 16 years old female patient who experienced child was difficult to awake her eyes were open, but she was not there, it shook her brain like a train went through it, child slumped over onto the nurse right after the injections, complained of a headache/increased headache, sensory overload, dizziness, teeth chattering, enlarged pupils, started having vision sensitivity to light and depth perception after receiving vaccines INFLUENZA VACCINE and MENINGOCOCCAL VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Nov-2022, the patient received a 0.5 ml (once) dose of suspect MENINGOCOCCAL VACCINE produced by unknown manufacturer (lot U7596AA) (strength, formulation and expiry date: unknown) via unknown route in the right arm and on the same day patient also received INFLUENZA VACCINE produced by unknown manufacturer (dose, strength, formulation and expiry date: unknown) (lot UT7683LA) via unknown route in the left arm both as Immunization.  On 01-NOV-2022 (latency: same day), the patient developed child was difficult to awake her eyes were open, but she was not there (somnolence), it shook her brain like a train went through it (cerebral disorder), child slumped over onto the nurse right after the injections (fall) and complained of headache/increased headache (headache) following the administration of both the suspects. On an unknown date the patient developed sensory overload, dizziness, teeth chattering (chills), enlarged pupils (mydriasis), started having vision sensitivity to light (photophobia) and depth perception (altered visual depth perception) (latency: 4 days) following the administration of both the suspects.  No lab data was reported.  Action taken: not applicable for both the suspects.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Recovered / Resolved in 2022 for the event child was difficult to awake her eyes were open, but she was not there and Unknown for all the other events.  Seriousness criteria: Medically significant for the event the patient developed child was difficult to awake her eyes were open, but she was not there (somnolence).; Sender's Comments: Sanofi Company Comment dated 13-Jan-2023: This case involves a 16 years old female patient who experienced child was difficult to awake her eyes were open, but she was not there, it shook her brain like a train went through it, child slumped over onto the nurse right after the injections, complained of a headache/increased headache, sensory overload, dizziness, teeth chattering, enlarged pupils, started having vision sensitivity to light and depth perception after receiving vaccines influenza vaccine and meningococcal vaccine. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, 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.