Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Ocular discomfort
Clinical narrative: "Flares" up around the face/in a "groove"; Eyes also get feeling as if wind blowing into them; Burning sensation; Idiopathic neuropathy; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Idiopathic neuropathy) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Iodine allergy and Hay fever.   On 13-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jun-2021, the patient experienced NEUROPATHY PERIPHERAL (Idiopathic neuropathy) (seriousness criterion medically significant). In September 2021, the patient experienced BURNING SENSATION (Burning sensation). On an unknown date, the patient experienced ECZEMA ("Flares" up around the face/in a "groove") and OCULAR DISCOMFORT (Eyes also get feeling as if wind blowing into them). The patient was treated with GABAPENTIN (GRALISE) (oral) ongoing from 12-Jul-2021 for Adverse event, at a dose of 1800 milligram once a day; VITAMIN B12 [VITAMIN B12 NOS] for Adverse event, at an unspecified dose and frequency; KRILL OIL for Adverse event, at an unspecified dose and frequency and ALPHA LIPOIC ACID for Adverse event, at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (Idiopathic neuropathy), ECZEMA ("Flares" up around the face/in a "groove") and BURNING SENSATION (Burning sensation) had not resolved and OCULAR DISCOMFORT (Eyes also get feeling as if wind blowing into them) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Aug-2021, Electromyogram: neuropathy (abnormal) The test confirmed the patient has neuropathy. On 11-Sep-2021, Magnetic resonance imaging head: normal (normal) MRI of the brain was done and the results were normal.. On an unknown date, Blood test: negative (Negative) Confirmed negative for diabetes and lymes disease and B12 deficiency.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication including steroids was reported. Concomitant medications was not reported. He stated he initially went to a "foot doctor". Later consulted a neurologist who confirmed idiopathic neuropathy with EMG test(nerve conduction test).  Company comment: This case concerns a 59-year-old, male patient with no relevant medical history, who experienced the unexpected serious adverse event of Neuropathy peripheral.  The event occurred approximately 3 months and 20 days after the second dose of Spikevax. The rechallenge was assessed as not applicable as the AEs occurred after the second dose. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up included case upgraded to serious, patient demographic details, lab details, time of vaccination, start date of event, event outcome, and treatment information.; Sender's Comments: This case concerns a 59-year-old, male patient with no relevant medical history, who experienced the unexpected serious adverse event of Neuropathy peripheral.  The event occurred approximately 3 months and 20 days after the second dose of Spikevax. The rechallenge was assessed as not applicable as the AEs occurred after the second dose. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.