Age: 20.0
Sex: F
Vaccine: FLUC3
Symptoms: Clumsiness, Feeling cold, Feeling drunk, Gait disturbance, Incoherent
Clinical narrative: Incoherent; Psychosis; Agitation; Aseptic meningitis; High CSF WBC; High CSF cell count; High RBC; "Seems drunk"; Temperature is low; Complains about being cold although she is warm to the touch; Trouble walking; "Clumsy"; This spontaneous case was received on 27-Jan-2023 from other non-healthcare professional via Agency (reference number: SEQW23-00381) and concerned a 20-year-old, female patient.  The patient's concurrent conditions included attention deficit hyperactivity disorder (ADHD). The patient had no sexually transmitted diseases (STDs). The patient's past medical history included tuberculosis, as reported the patient tested positive for tuberculosis in the past although, at the time of reporting, exhibited no symptoms. The patient's concomitant medications included unspecified norepinephrine reuptake inhibitor (NRI) used for an unreported indication.   On 10-Jan-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for prevention of influenza disease caused by influenza virus subtypes A and B contained in the vaccine. The batch number reported was not reported and expiry date was reported as 'in 2023'.   On 13-Jan-2023, ten days before the reaction as reported, the patient started taking non-company, co-suspect Strattera (atomoxetine hydrochloride; dose: 80 mg, route of administration, frequency and indication: not reported). The batch number was not reported.    On 23-Jan-2023, 13 days after receiving Flucelvax Quadrivalent and ten days after starting non-company co-suspect Strattera, the patient became incoherent and started experiencing psychosis and agitation.   On the same day, the patient was admitted to hospital.  While in the hospital, patient was given Precedex (dexmedetomidine hydrochloride) so she could be still and take a magnetic resonance imaging (MRI). The patient was given barbiturates and benzodiazepines namely Valium (diazepam) such was her agitation but remained incoherent and combative leading to her being put into a drug-induced coma (also reported as only to end up in "something of a coma"). The patient was put on a drip. Doctors wanted to give her an antiviral but then decided against it. Although unsure, the doctors believed the patient might had aseptic meningitis.   On an unspecified date in Jan-2023, the patient underwent cerebrospinal fluid (CSF) puncture, and the results were still pending (reported as 'still waiting for the result'). Although, the reporter stated that the patient had high red blood cell (RBC) as well as CSF white blood cell (WBC) and CSF cell count.   On 24-Jan-2023, the patient was discharged from the hospital.   On an unspecified date in Jan-2023 (reported 'as of now'), the patient was awake and alert but hadn't recovered from the reaction. In fact, the patient "seemed drunk", her temperature was low, and the patient complained about being cold although she was warm to the touch. The patient was coherent, had trouble walking and was "clumsy". Reporter concluded: "She's not the child we know".  On an unspecified date in Jan-2023, the patient recovered from events of incoherent. As reported, the patient was coherent.   At the time of initial reporting, the patient had not recovered from all other events. As reported, the patient hadn't recovered from the reaction.  The reporter did not provide causality assessment.  The events of aseptic meningitis, 'CSF WBC increased', 'CSF cell count increased', 'RBC count increased', incoherent, psychosis and agitation were assessed as serious due to seriousness criterion of hospitalization. Additionally, the events of aseptic meningitis, aseptic meningitis, 'CSF WBC increased' and 'CSF cell count increased' were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 20-year-old, female patient was vaccinated with Flucelvax Quadrivalent. Three days later, the patient started taking non-company, co-suspect Strattera (atomoxetine hydrochloride). Thirteen days after receiving Flucelvax Quadrivalent and ten days after starting non-company co-suspect Strattera, the patient became incoherent and started experiencing psychosis and agitation. On the same day, the patient was admitted to hospital. The patient was given barbiturates and benzodiazepines, the patient remained incoherent and combative, leading to her being put into a drug-induced coma. Reportedly, the doctors believed the patient might had aseptic meningitis. The patient underwent cerebrospinal fluid puncture, and the results were still pending. The patient had high red blood cell as well as CSF white blood cell and CSF cell count. Next day, the patient was discharged from the hospital. Eventually, the patient was awake and alert, however seemed drunk with low temperature, considering that the patient complained about being cold although she was warm to the touch. In addition, the patient was coherent, had trouble walking and was clumsy, as reported. Causality was confounded by the therapy with the non-company, co-suspect Strattera. Causal role of the suspect vaccine is unassessable for the events meningitis aseptic, CSF white blood cell count increased, CSF cell count increased, red blood cell count increased, incoherent, psychotic disorder, agitation, feeling drunk, body temperature decreased, feeling cold, gait disturbance and clumsiness, with the currently available information.; Sender's Comments: A 20-year-old, female patient was vaccinated with Flucelvax Quadrivalent. Three days later, the patient started taking non-company, co-suspect Strattera (atomoxetine hydrochloride). Thirteen days after receiving Flucelvax Quadrivalent and ten days after starting non-company co-suspect Strattera, the patient became incoherent and started experiencing psychosis and agitation. On the same day, the patient was admitted to hospital. The patient was given barbiturates and benzodiazepines, the patient remained incoherent and combative, leading to her being put into a drug-induced coma. Reportedly, the doctors believed the patient might had aseptic meningitis. The patient underwent cerebrospinal fluid puncture, and the results were still pending. The patient had high red blood cell as well as CSF white blood cell and CSF cell count. Next day, the patient was discharged from the hospital. Eventually, the patient was awake and alert, however seemed drunk with low temperature, considering that the patient complained about being cold although she was warm to the touch. In addition, the patient was coherent, had trouble walking and was clumsy, as reported. Causality was confounded by the therapy with the non-company, co-suspect Strattera. Causal role of the suspect vaccine is unassessable for the events meningitis aseptic, CSF white blood cell count increased, CSF cell count increased, red blood cell count increased, incoherent, psychotic disorder, agitation, feeling drunk, body temperature decreased, feeling cold, gait disturbance and clumsiness, with the currently available information.