Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Ear congestion, Ear pain, Fatigue, Loss of personal independence in daily activities
Clinical narrative: Unable to do many activities including camping; nausea; fatigue; Sudden onset of bilateral tinnitus/ Humming and buzzing; Fullness in both ears/bilateral tinnitus, fullness and ear pressure; pressure in both ears/bilateral tinnitus, fullness and ear pressure; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Sudden onset of bilateral tinnitus/ Humming and buzzing), EAR CONGESTION (Fullness in both ears/bilateral tinnitus, fullness and ear pressure), EAR PAIN (pressure in both ears/bilateral tinnitus, fullness and ear pressure), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do many activities including camping) and NAUSEA (nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.  Concomitant products included FISH OIL from 11-Jan-2018 to an unknown date for Dry eye, ESTRADIOL (ESTRACE VAGINAL) from 03-Jan-2015 to an unknown date for Dryness vaginal, VIT D [VITAMIN D NOS] from 11-Jan-2018 to an unknown date for Immune disorder (NOS), ZOLPIDEM TARTRATE (AMBIEN) from 01-Jan-2018 to an unknown date for Sleep disorder NOS.   On 16-Feb-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021 at 8:30 PM, the patient experienced TINNITUS (Sudden onset of bilateral tinnitus/ Humming and buzzing), EAR CONGESTION (Fullness in both ears/bilateral tinnitus, fullness and ear pressure) and EAR PAIN (pressure in both ears/bilateral tinnitus, fullness and ear pressure). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do many activities including camping), NAUSEA (nausea) and FATIGUE (fatigue). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form and MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) at a dose of 1 dosage form. At the time of the report, TINNITUS (Sudden onset of bilateral tinnitus/ Humming and buzzing), EAR CONGESTION (Fullness in both ears/bilateral tinnitus, fullness and ear pressure) and EAR PAIN (pressure in both ears/bilateral tinnitus, fullness and ear pressure) had not resolved and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do many activities including camping), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Acoustic stimulation tests: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Patient asked PCP for a round of steroids around week 11 of SX as pretty disparate at that point. Did 10 day 60-40-20-10 mg taper. Fullness and pressure improved but still with side effects from steroids to include nausea and fatigue.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Added concomitant medications, events added