Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Myelitis transverse, Positron emission tomogram, Speech disorder, Tremor
Clinical narrative: Transverse myelitis; Non-stop pain in the spinal area/back pain; Inflammation of the nerves going into spine and spinal cord; Loss of mobility and speaking; Loss of mobility and speaking; Could not walk; Body tremors; This spontaneous case was received on 11-Jan-2021 from other non-health professional (consumer) via regulatory authority (reference number: SEQW21-00125) with additional information received on 12-Jan-2021 (being processed together) and concerned a 70-year-old female patient.  The patient's relevant medical history was not reported. The patient's concomitant medication included lovastatin, used for an unreported indication.  On 07-Oct-2020, the patient was vaccinated with adjuvanted Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose, route of administration, indication and anatomical location: not reported). The batch number reported was 279813, the expiry date: 30-Jun-2021.   On 09-Nov-2020, one month and two days after receiving Fluad Quadrivalent, the patient experienced severe back pains which became more painful as the day went on. That evening, she was taken to hospital and admitted. The patient had severe inflammation of the nerves going into the spine and spinal cord. She was diagnosed with transverse myelitis and was treated with three large steroid infusion at dose of 1000 mg each during the course of week.   On 14-Nov-2020, the patient was discharged from the hospital.  On an unspecified date in Nov-2020, the following week as reported, things did not improve, and a repeat of the steroid treatments was conducted.  On an unspecified date in 2020, things became even worse. She could not walk; the intense pain was causing severe body tremors and speech was impacted.    On 05-Dec-2020, the patient was admitted to another hospital. The specialist did not agree with the previous diagnosis but had not been able to identify the cause or remedy for what she was going throw. Countless tests have been performed, trying to determine the cause but nothing had been found yet. The tests included magnetic resonance imaging (MRIs), computed tomography (Cat Scans), positron emission tomography (Pet) scan, spinal taps, blood tests, electroencephalogram (EEG) and electromyography (EMG), and the results were not reported.   On 18-Dec-2020, the patient was discharged from the hospital.  On an unspecified day, the patient was treated with medications (meds) that had controlled the pain to a manageable level and the patient was going to physical therapy. The patient had a long way to go to get back to normal.  At the time of initial reporting on 11-Jan-2021, the patient had not recovered from the events.  The reporter did not provide causality assessment.  The event of 'myelitis transverse' was considered serious due to the criterion of hospitalisation and medical significance, while the other events were considered serious due to hospitalisation.  Company comment: A 70-year-old female patient experienced myelitis transverse, back pain, mobility decreased, aphasia, gait inability, tremor and neuritis one month and two days after administration of Fluad Quadrivalent. The patient performed series of tests including magnetic resonance imaging (MRIs), computed tomography (Cat Scans), positron emission tomography (Pet) scan, spinal taps, blood tests, electroencephalogram (EEG) and electromyography (EMG), however the results were not reported. The patient's relevant medical history was not reported. Concomitant medication included lovastatin, used for an unreported indication. Causality is assessed as possibly related for all events due to biological, chronological plausibility and lack of confounding factors.; Sender's Comments: A 70-year-old female patient experienced myelitis transverse, back pain, mobility decreased, aphasia, gait inability, tremor and neuritis one month and two days after administration of Fluad Quadrivalent. The patient performed series of tests including magnetic resonance imaging (MRIs), computed tomography (Cat Scans), positron emission tomography (Pet) scan, spinal taps, blood tests, electroencephalogram (EEG) and electromyography (EMG), however the results were not reported. The patient's relevant medical history was not reported. Concomitant medication included lovastatin, used for an unreported indication. Causality is assessed as possibly related for all events due to biological, chronological plausibility and lack of confounding factors.