Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: delayed Bell's palsy like event; worsened condition; nasal sounds; Prickling/tingling sensation; Right face had been slightly numb; meniere disease; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MENIERE'S DISEASE (meniere disease) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension since 01-Jan-2014. Concomitant products included LISINOPRIL for an unknown indication.   On 09-Jan-2021 at 3:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced MENIERE'S DISEASE (meniere disease) (seriousness criterion medically significant), CONDITION AGGRAVATED (worsened condition) and NASAL DISCOMFORT (nasal sounds). 31-Jan-2021, the patient experienced PARAESTHESIA (Prickling/tingling sensation) and HYPOAESTHESIA (Right face had been slightly numb). The patient was treated with ACETAZOLAMIDE at an unspecified dose and frequency. At the time of the report, MENIERE'S DISEASE (meniere disease), CONDITION AGGRAVATED (worsened condition) and NASAL DISCOMFORT (nasal sounds) had not resolved and PARAESTHESIA (Prickling/tingling sensation) and HYPOAESTHESIA (Right face had been slightly numb) outcome was unknown.            The patient stated that the headache tinnitus and ear pressure continued after dose 2. the patient started having nasal sounds, took over the counter medications (Sudafed, Afrin, Tylenol, Ibuprofen) but no improvement and went to the health clinic where doctor prescribed neomycin and polymyxin drops and amoxicillin.  Patient went to ENT (Feb 25) who diagnosed Menier's disease and prescribed 5 day course of Prednisone and that afternoon experienced pronounced paresthesia (from the right lip to the temple). On 27 Feb 21, the patient experienced heart palpatations likely from prednisone and/or anxiety, went to ER had Chest X-ray, EKG, bloodwork and was discharged a few hours. Headaches and facial pressure came off while on prednisone.  March 2-3 come off prednisone, headaches and pressure return, along with paresthesia continuing and again went to ER. All labs, MRI and CT scan came back normal.  March 3 went to see neurologists and had blood work and MRI which was unremarkable.  March 5 MRI with and without contrast showed is a vein near auditory canal on left side, followed up EEG but unremarkable. Started on Claritin mid-March for a week, headaches and pressure go from constant to occasional and Zyrtec, Singulair (prescribed), and Flonase (prescribed), but no significant improvement next few weeks.  On 02 April 21, was diagnosed with autoimmune attack of cranial nerves likely because of vaccine and was prescribed Nortriptyline for 1 month for headaches. On 07 April 21, hearing test came back normal, and mid-April headaches and pressure completely stopped but tinnitus remains. Again, started taking prednisone but no improvement.  04 May 21, nortriptyline was stopped, was prescribed acetazolamide after suggesting delayed Bell's Palsy like reaction.  10 May 21, immunologist also suggested delayed Bell's Palsy like reaction that may or may not be vaccine caused. Tinnitus responded to acetazolamide.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.