Age: 46.0
Sex: F
Vaccine: FLUC3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia oral, Immunoglobulin therapy, Lumbar puncture normal
Clinical narrative: Tongue was numb; Diagnosed with CIDP (chronic inflammatory demyelinating polyradiculoneuropathy)/MRI compatible with GBS CIPD; Bil hand weakness; Feet and leg pain/symptoms got worse; Numbness of bil toes/bil hand numbness; This spontaneous case was retrieved on 15-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1383792-1), reported by other non-healthcare professional (patient) and concerned a 46-year-old, female patient.  The patient's concurrent conditions included hypothyroidism and depression. The patient's concomitant medications included Armour thyroid (thyroid), Wellbutrin (bupropion hydrochloride), unspecified multivitamins and vitamin B complex, all used for an unreported indication.   On 18-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular, anatomical location: left arm, dose reported as one and indication: not reported). The batch number was reported as 276558.   On 31-Oct-2020 (also reported as by 10/20) one month and 13 days after receiving Flucelvax Quadrivalent, the patient experienced feet and leg pain and symptoms got worse moving forward.   On an unknown date in 2020 by Dec-2020 (reported as 12/20), unknown amount of time after receiving Flucelvax Quadrivalent, the patient noticed numbness of bilateral toes.   On 14-Jan-2021, the patient got appointment with neuro doctor, who ordered blood work, urine and electromyogram (EMG) and put the patient on gabapentin.   On an unspecified date in Mar-2021, EMG was done.  On 27-Apr-2021, the patient had follow up visit with the neuro doctor, when she told to the patient that EMG was abnormal and that rest of blood work was normal. Doctor ordered magnetic resonance imaging (MRI) of thoracic and lumbar and changed gabapentin for amitriptyline. By this point, the patient was experiencing numbness and weakness on bilateral hand.  On 07-May-2021, thoracic and lumbar MRI was done.   On 18-May-2021, the patient had another follow up visit with the neuro doctor when she gave her the diagnosis of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), since MRI was compatible with Guillain-Barre syndrome / chronic inflammatory demyelinating polyneuropathy (GBS/CIDP).  Patient was put on unspecified steroids, intravenous immunoglobulin and doctor drew more blood for antibodies, and also ordered lumbar puncture, which subsequently came back normal.  On 19-May-2021, the patient finished her fourth round of intravenous immunoglobulin infusion.  On 24-May-2021, the patient's tongue was numb, so she went to emergency room (ER) and was admitted to hospital for five days.  On 29-May-2021, the patient was discharged from hospital.   At the time of initial reporting, the patient had not recovered from none of the events. As reported, symptoms got worse more.  The reporter did not provide causality assessment.  All events were assessed as serious due to seriousness criterion of hospitalization and disability. Additionally, the event of 'CIDP' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A 46-year-old, female patient was vaccinated with Flucelvax Quadrivalent. One month and 13 days following vaccination, the patient experienced feet and leg pain. In addition, the patient developed numbness of bilateral toes and numbness and weakness on bilateral hand. The patient was diagnosed with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), since MRI was compatible with Guillain-Barre syndrome / chronic inflammatory demyelinating polyneuropathy (GBS/CIDP) as per neuro doctor. The patient was put on unspecified steroids and intravenous immunoglobulin. Fifth day, following fourth round of intravenous immunoglobulin infusion, the patient's tongue was numb. Causality for the reported events is assessed as possibly related due to plausible temporal relationship. Agency criteria for the event Guillain-Barre syndrome could not be assessed due to insufficient information provided.; Sender's Comments: A 46-year-old, female patient was vaccinated with Flucelvax Quadrivalent. One month and 13 days following vaccination, the patient experienced feet and leg pain. In addition, the patient developed numbness of bilateral toes and numbness and weakness on bilateral hand. The patient was diagnosed with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), since MRI was compatible with Guillain-Barre syndrome / chronic inflammatory demyelinating polyneuropathy (GBS/CIDP) as per neuro doctor. The patient was put on unspecified steroids and intravenous immunoglobulin. Fifth day, following fourth round of intravenous immunoglobulin infusion, the patient's tongue was numb. Causality for the reported events is assessed as possibly related due to plausible temporal relationship. Agency criteria for the event Guillain-Barre syndrome could not be assessed due to insufficient information provided.