Age: 13.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Blood test, Dyskinesia, Fatigue, Headache, Mood altered
Clinical narrative: Seizure-like activity; Incontrollable muscle movement; Mood change; Muscle weakness; Cramps; Nausea; Tired; Headache; This spontaneous case was received on 05-Oct-2020 from other non-health professional via agency and concerned a 13-year-old, female patient.   The patient had no relevant medical history and was not taking any concomitant medications.  On 27-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 287096.   On 28-Sep-2020, one day after receiving Flucelvax QIV, the patient experienced seizure-like activity, incontrollable muscle movement, mood change, muscle weakness, cramps, nausea, headache and was tired.    On 03-Oct-2020, the patient was admitted to hospital. On the same date, the patient was discharged from the hospital.   On unknown date in 2020, the patient had a bloodwork test and was treated with unspecified steroids.    At the time of initial reporting on 05-Oct-2020, the patient had not recovered from the events. The patient's symptoms were still ongoing, and patient was being followed by a neurologist.   The reporter assessed the events as related to Flucelvax QIV. The reporter called to report an adverse event following Flucelvax QIV administration.  The event of 'seizure' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  This case is linked to cases 202004934 (the corresponding mother case) and 202004936 (the corresponding father case).  Company comment: A 13-year-old, female patient experienced seizure (seizure like symptoms), dyskinesia, mood altered, muscular weakness, muscle cramps, nausea, headache and fatigue one day after receiving Flucelvax QIV vaccine. The patient had no relevant medical history and was not taking any concomitant medications. Reportedly, six days after vaccination the patient was admitted to hospital and discharged on the same date. On unknown date in 2020, the patient had a bloodwork test and was treated with unspecified steroids. More information regarding diagnostic findings is needed. The reporter assessed the events as related to Flucelvax QIV. Causality is assessed as possibly related for all events due to plausible chronology and no alternative aetiology provided. Brighton Collaboration criteria for generalised tonic-clonic seizure could not be assessed due to insufficient information.; Sender's Comments: A 13-year-old, female patient experienced seizure (seizure like symptoms), dyskinesia, mood altered, muscular weakness, muscle cramps, nausea, headache and fatigue one day after receiving Flucelvax QIV vaccine. The patient had no relevant medical history and was not taking any concomitant medications. Reportedly, six days after vaccination the patient was admitted to hospital and discharged on the same date. On unknown date in 2020, the patient had a bloodwork test and was treated with unspecified steroids. More information regarding diagnostic findings is needed. The reporter assessed the events as related to Flucelvax QIV. Causality is assessed as possibly related for all events due to plausible chronology and no alternative aetiology provided. Brighton Collaboration criteria for generalised tonic-clonic seizure could not be assessed due to insufficient information.