Age: 42.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Mood altered, Muscle spasms, Muscular weakness, Nausea, Pain
Clinical narrative: Seizure-like activity; Incontrollable muscle movement; Muscle weakness; Mood change; Cramps; Headache; Tired; Nausea; Migraine; Pain; This spontaneous case was received on 05-Oct-2020 from other non-health professional (consumer) via call center and concerned a 42-year-old, female patient.   The patient had no relevant medical history. The patient's concomitant medication included estrogens for unreported indication.  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 unknown date in 2020, the patient developed migraine and pain.  On 02-Oct-2020, the patient was admitted to hospital and had a computed tomography (CT) scan, but results were not provided. The patient was treated with unspecified intravenous (IV) fluid, steroids (prednisone), migraine medicine and medication for pain. On the same date, the patient was discharged from hospital.   At the time of initial reporting on 05-Oct-2020, the patient had not recovered from the events of seizure-like activity, incontrollable muscle movement, mood change, muscle weakness, cramps, nausea, headache and tired. The patient's symptoms were still ongoing, and patient was being followed by a neurologist.   The outcome of the events migraine and pain was not reported.  The reporter did not provide causality assessment. The reporter called to report an adverse event following Flucelvax QIV administration.   The event of 'seizure' was considered to be serious due to medically significance by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  This case is linked to cases 202004935 (the corresponding daughter case) and 202004936 (the corresponding husband case).  Company comment: A 42-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. On unknown date in 2020, the patient developed migraine and pain. Reportedly, the patient had a computed tomography (CT) scan, but results were not provided. The patient was treated with unspecified intravenous (IV) fluid, steroids (prednisone), migraine medicine and medication for pain. More information regarding diagnostic findings is needed. The patient's concomitant medication included estrogens for unreported indication. Due to unclear chronology for migraine and pain, and confounding treatment with estrogens, causality is unassessable with information available. For all other events, causality is assessed as possibly related due to plausible chronology. Brighton Collaboration criteria for generalised tonic-clonic seizure could not be assessed due to insufficient information.; Sender's Comments: A 42-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. On unknown date in 2020, the patient developed migraine and pain. Reportedly, the patient had a computed tomography (CT) scan, but results were not provided. The patient was treated with unspecified intravenous (IV) fluid, steroids (prednisone), migraine medicine and medication for pain. More information regarding diagnostic findings is needed. The patient's concomitant medication included estrogens for unreported indication. Due to unclear chronology for migraine and pain, and confounding treatment with estrogens, causality is unassessable with information available. For all other events, causality is assessed as possibly related due to plausible chronology. Brighton Collaboration criteria for generalised tonic-clonic seizure could not be assessed due to insufficient information.