Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Vitamin B12 normal, West Nile virus test negative
Clinical narrative: Sensory polyradiculopathy; This is a spontaneous case was retrieved on 25-Feb-2019 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 783544-1) reported by other non-health professional (consumer) and concerned a 76-year-old, male patient.  The patient's past medical history included spinal stenosis requiring a C2-C7 laminectomy. The patient's concurrent medical history included hypertension, hyperlipidaemia, hyperuricemia, gout, hypothyroidism, thrombocytopenia and penicillin allergy. The patient's past medication included allopurinol on which the patient developed bone marrow depression (40 years before initial reporting). The patient's concomitant medications included levothyroxine, atorvastatin, potassium citrate, metoprolol succinate, tamsulosin, vitamin D3 (colecalciferol), Vitamin B12 (cyanocobalamin) and Metamucil (plantago ovata).  On 02-Oct-2018, the patient was vaccinated with Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: arm) as flu prevention.  The batch number reported was 250793.  On an unspecified date in Oct-2018, two weeks after receiving Fluad (TIV), the patient experienced upper back pain which radiated bilaterally to the chest and abdomen from the level of the nipples to the lower abdomen. The pain was accompanied by a burning feeling, skin hypersensitivity/high sensitivity and tenderness. The pain radiated anteriorly to about the nipple level and did not involve the sternal area.   On an unspecified date in 2018, after receiving Fluad (TIV), magnetic resonance imaging (MRI) of the thoracic spine was done, but the results were not reported. Blood sedimentation rate revealed normal result, complete blood count (CBC) revealed normal results except for a thrombocytopenia since the allopurinol episode which was about 40 years before initial reporting. Lyme and West Nile virus profile revealed negative results and vitamin B12 revealed normal result.  On an unspecified date, after receiving Fluad (TIV), the patient saw a neurologist and did additional studies and was diagnosed with a sensory polyradiculopathy. The patient was treated with gabapentin which was helpful and the symptoms gradually resolved and the patient discontinued the gabapentin.  On an unspecified date, the patient recovered from the event.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Non-significant case amendment (25-Feb-2019): The description as reported for the event 'chest pain' was rephrased from 'Upper back pain which radiated bilaterally to the chest' to "[Upper back] pain which radiated bilaterally to the chest' and for event 'abdominal pain' from 'Upper back pain which radiated bilaterally to the [chest and] abdomen from the level of the nipples to the lower abdomen' to '[Upper back] pain which radiated bilaterally to the [chest and] abdomen from the level of the nipples to the lower abdomen' in the event tab no changes were made in the narrative.  Additional information received on 30-Oct-2020 from physician via Health Authority (reference number: SEQW20-04524): The reporter type updated form 'other non-health professional' to 'physician' and whole case and event changed from medically confirmed 'No' to 'Yes'. All null flavours changed, while intermediary was removed and report sent to regulatory authority by reporter changed from 'Yes' to 'No'. Magnetic resonance imaging (MRI) deleted from lab data since no results were provided. Vaccine indication was provided. Treatment with gabapentin was added. All events were deleted since the diagnose was provided and added as event with updated start date and outcome. Thrombocytopenia was moved to medical history and the case was downgraded from serious to non-serious. The narrative was amended accordingly.  Additional non-significant information received on 09-Nov-2020 from partner: Reference number added. No changes in narrative.  Company comment: A 76-year-old male patient with medical history of spinal stenosis requiring a C2-C7 laminectomy and current conditions (hypertension, hyperlipidaemia, hyperuricemia, gout, hypothyroidism, and thrombocytopenia, reported as medical history) experienced sensory polyradiculopathy which radiated bilaterally to the chest and abdomen from the level of the nipples to the lower abdomen and the pain was accompanied by a burning feeling and skin hypersensitivity, 9 days after receipt of Fluad TIV. The event of sensory polyradiculopathy could be alternatively explained by underlying risk factors (medical history of spinal stenosis requiring a C2-C7 laminectomy). The company assessed the reported event as not related due to the alternative more plausible causes for the event rather than the suspect vaccine.; Sender's Comments: A 76-year-old male patient with medical history of spinal stenosis requiring a C2-C7 laminectomy and current conditions (hypertension, hyperlipidaemia, hyperuricemia, gout, hypothyroidism, and thrombocytopenia, reported as medical history) experienced sensory polyradiculopathy which radiated bilaterally to the chest and abdomen from the level of the nipples to the lower abdomen and the pain was accompanied by a burning feeling and skin hypersensitivity, 9 days after receipt of Fluad TIV. The event of sensory polyradiculopathy could be alternatively explained by underlying risk factors (medical history of spinal stenosis requiring a C2-C7 laminectomy). The company assessed the reported event as not related due to the alternative more plausible causes for the event rather than the suspect vaccine.