Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Deafness bilateral, Ear, nose and throat examination, Tinnitus
Clinical narrative: Intermittent tinnitus improving but not resolved; Bilateral mild to severe sensorineural hearing loss/Bilateral static L greater than R; This literature-non-study case was reported in a literature article and describes the occurrence of DEAFNESS BILATERAL (Bilateral mild to severe sensorineural hearing loss/Bilateral static L greater than R) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.      Concurrent medical conditions included Hypertension, Iron overload since 2016, Migraine headache and Osteoporosis. Concomitant products included ATENOLOL, VITAMIN D NOS, CYANOCOBALAMIN and ASA for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient experienced DEAFNESS BILATERAL (Bilateral mild to severe sensorineural hearing loss/Bilateral static L greater than R) (seriousness criterion medically significant). On an unknown date, the patient experienced TINNITUS (Intermittent tinnitus improving but not resolved). At the time of the report, DEAFNESS BILATERAL (Bilateral mild to severe sensorineural hearing loss/Bilateral static L greater than R) had not resolved and TINNITUS (Intermittent tinnitus improving but not resolved) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Ear, nose and throat examination: bilateral mild to severe sensorineural hearing loss.. On an unknown date, Audiogram: WRS 100%. R type A tymp, LAD..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DEAFNESS BILATERAL (Bilateral mild to severe sensorineural hearing loss/Bilateral static L greater than R) to have an unknown relationship. No further causality assessment was provided for TINNITUS (Intermittent tinnitus improving but not resolved).    Patient did not receive any treatment and no imaging was performed.  Concomitant medications were reported as odipine and Bonasa. Concurrent condition was reported as tarad. Patient had no allergies.  Adverse event did not cause patient to seek medical care. Patient did not experience similar adverse events in the past and there were no other potential causes for adverse events.  It was unknown if, patient was tested positive for COVID-19 in the past.  Authors discussed that patients were identified as having possible covid vaccine related tinnitus if they reported tinnitus onset within four weeks of any COVID-19 vaccine dose, no other attributable cause was identified, had an audiogram after onset of symptoms and at least one visit with our Otolaryngologists. The timeframe of onset of tinnitus within four weeks of a COVID-19 vaccine was chosen as a reasonable timeframe for a patient and provider to rule out other possible explanations for the onset of their tinnitus (such as a noise exposure, new medication, etc.).  Authors concluded that a correlation cannot be proven with this retrospective study with such few cases, however, patients will still present to their medical providers with tinnitus with and without hearing loss after a COVID-19 vaccination.  Company comment: This literature non study case concerns a 80-year-old, female patient with no medical history information reported, who experienced the unexpected serious (medically significant) event of deafness bilateral and non serious event of tinnitus. The events occurred approximately 5.5 months after the second dose of mRNA-1273. As reported the patient experienced Bilateral mild to severe sensorineural hearing loss/Bilateral static L greater than R. On unknown date WRS was 100%. No treatment was provided. The patient received 3rd dose of vaccine 3 months after event onset. Considering patient's age and non suggestive temporal relation causality for the events is assessed as not related. The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2023-718642 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718642:Master case