Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm was sore; problem with her right ear it was like a fullness in the ear; problem with the Eustachian tube; tinnitus; moderate hearing loss in one ear/sudden hearing loss; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS UNILATERAL (moderate hearing loss in one ear/sudden hearing loss), EAR DISCOMFORT (problem with her right ear it was like a fullness in the ear), EUSTACHIAN TUBE DYSFUNCTION (problem with the Eustachian tube) and TINNITUS (tinnitus) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A and 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoporosis and Atrial fibrillation (one occurrence of atrial fibrillation in March 2021) since March 2021. Concomitant products included APIXABAN (ELIQUIS) for Atrial fibrillation.   On 20-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, the patient experienced EAR DISCOMFORT (problem with her right ear it was like a fullness in the ear) (seriousness criterion medically significant). In April 2022, the patient experienced DEAFNESS UNILATERAL (moderate hearing loss in one ear/sudden hearing loss) (seriousness criteria disability and medically significant), EUSTACHIAN TUBE DYSFUNCTION (problem with the Eustachian tube) (seriousness criterion medically significant) and TINNITUS (tinnitus) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION SITE PAIN (arm was sore). The patient was treated with PREDNISONE for Hearing loss, at a dose of high dose and CORTISONE at a dose of three weeks. At the time of the report, DEAFNESS UNILATERAL (moderate hearing loss in one ear/sudden hearing loss) had not resolved and EAR DISCOMFORT (problem with her right ear it was like a fullness in the ear), EUSTACHIAN TUBE DYSFUNCTION (problem with the Eustachian tube), TINNITUS (tinnitus) and VACCINATION SITE PAIN (arm was sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: showed moderate hearing loss in one ear and another test showed no improvement.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient height was 5'2.  Patient did not had COVID positive test or diagnosis and did not received any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  The patient wants to report something 6 months ago and understands the new shot was 50 percent of the old shot and 50 percent of the new shot. Patient was hesitant to take the new vaccine.   On 31-Mar-2022, she had the second booster Moderna. On 05-Apr-2022 end of the day, patient had a problem with right ear, and it was like a fullness in the ear, patient had been in the pool, so didn't associate it with the vaccine, thought there was water in the ear. Both the primary and an ENT said it was a problem with the Eustachian tube. A few weeks later, the third doctor said to wait a month and then take a hearing test, got a fourth doctor to do a hearing test right away. The test showed moderate hearing loss in one ear. patient described it as a sudden hearing loss. They couldn't figure out the cause.   The patient states that it might have treated it earlier, they may have been able to reverse the hearing loss. Patient also had tinnitus that came with the hearing loss. The patient was concerned about getting another shot if patients other ear will be affected. The patient adds that patient's arm was sore after the shots.   Patient had 2 weeks of high dose prednisone, but another test showed no improvement. For three weeks after that, patient received a cortisone injection directly into the ear every week. However, another hearing test showed no improvement again.  Company Comment: This spontaneous case reported by a patient concerns a 76-year-old female patient, with no relevant medical history, who experienced unexpected, serious (medically significant) events of ear discomfort, eustachian tube dysfunction, tinnitus, and deafness unilateral (also serious due to disability), after receiving a fourth dose (second booster) of mRNA-1273.  Around 5 days post-vaccination, she began feeling fullness in her right ear.  She had been in the pool and thought there was water in the ear; she did not associate it with the vaccine.  Ear, nose, and throat (ENT) doctor said there was a problem with the Eustachian tube.  A few weeks later, hearing test showed moderate hearing loss in one ear.  This was associated with tinnitus.  The cause of the hearing loss could not be determined.  She was treated with 2 weeks of high dose prednisone, followed by cortisone injections into the ear every week.  However, no improvement was noted on repeat hearing test.  The patients age could be a contributory factor for deafness.  The benefit risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-647029 (Patient Link).; Sender's Comments: This spontaneous case reported by a patient concerns a 76-year-old female patient, with no relevant medical history, who experienced unexpected, serious (medically significant) events of ear discomfort, eustachian tube dysfunction, tinnitus, and deafness unilateral (also serious due to disability), after receiving a fourth dose (second booster) of mRNA-1273.  Around 5 days post-vaccination, she began feeling fullness in her right ear.  She had been in the pool and thought there was water in the ear; she did not associate it with the vaccine.  Ear, nose, and throat (ENT) doctor said there was a problem with the Eustachian tube.  A few weeks later, hearing test showed moderate hearing loss in one ear.  This was associated with tinnitus.  The cause of the hearing loss could not be determined.  She was treated with 2 weeks of high dose prednisone, followed by cortisone injections into the ear every week.  However, no improvement was noted on repeat hearing test.  The patients age could be a contributory factor for deafness.  The benefit risk relationship of mRNA-1273 is not affected by this report.