Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Deafness neurosensory, Ear, nose and throat examination, Tinnitus
Clinical narrative: Sensorineural hearing loss; Left tinnitus 1.5 weeks after moderna; This literature-non-study case was reported in a literature article and describes the occurrence of DEAFNESS NEUROSENSORY (Sensorineural hearing loss) in a 64-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.   LITERATURE REFERENCE:    Concurrent medical conditions included Drug allergy (Allergic to drugs Atorvastatin and rosuvastatin), Breast cancer (Breast Cancer (CMS-HCC)) since November 2016, Cholesterol blood excessive (High cholesterol) and Kidney stone. Concomitant products included PARACETAMOL (TYLENOL), VITAMIN C [ASCORBIC ACID], VITAMIN D3, DOCUSATE SODIUM (COLACE), EXEMESTANE (AROMASIN), EZETIMIBE (ZETIA) and MELATONIN 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 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced TINNITUS (Left tinnitus 1.5 weeks after moderna). On 20-Apr-2021, the patient experienced DEAFNESS NEUROSENSORY (Sensorineural hearing loss) (seriousness criterion medically significant). At the time of the report, DEAFNESS NEUROSENSORY (Sensorineural hearing loss) outcome was unknown and TINNITUS (Left tinnitus 1.5 weeks after moderna) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Audiogram: Type A tympanograms WRS 100% bilateral. On 20-Apr-2021, Ear, nose and throat examination: This demonstrated a bilateral sensorineural hearing loss.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered TINNITUS (Left tinnitus 1.5 weeks after Moderna) to have an unknown relationship. No further causality assessment was provided for DEAFNESS NEUROSENSORY (Sensorineural hearing loss).    Treatment medications were not reported.  Patient did not experience similar adverse events in the past and there were no other potential causes for adverse events.  Patient was not 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 is a literature non-study case concerning a 64-year-old female patient with concurrent medical conditions of Drug allergy to Atorvastatin and rosuvastatin, Breast cancer since November 2016, Cholesterol blood excessive and Kidney stone and concomitant products which included paracetamol, vitamin C, vitamin D3, docusate sodium,  exemestane, ezetimibe and melatonin for an unknown indication, who experienced the serious (medically significant) unexpected event deafness neurosensory (reported as sensorineural hearing loss) and the non-serious event of tinnitus. Patient did not experience similar adverse events in the past and there were no other potential causes for adverse events. The event deafness neurosensory occurred 3 months after receiving the first a dose of mRNA-1273 vaccine and 2 months after receiving the second dose of mRNA-1273 vaccine. The event tinnitus 2 months after receiving the first a dose of mRNA-1273 vaccine and 1.5 weeks after receiving the second dose of mRNA-1273 vaccine. Relevant diagnostic tests included a type A tympanogram showing WRS 100% bilateral. Ear, nose, and throat examination demonstrated a bilateral sensorineural hearing loss. The outcome of the event deafness neurosensory was reported as unknown. The event tinnitus was reported as not resolved.  No treatment medications were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-718642, US-MODERNATX, INC.-MOD-2023-718642 (E2B Linked Report). Sender's Comments: Company Comment: This is a literature non-study case concerning a 64-year-old female patient with concurrent medical conditions of Drug allergy to Atorvastatin and rosuvastatin, Breast cancer since November 2016, Cholesterol blood excessive and Kidney stone and concomitant products which included paracetamol, vitamin C, vitamin D3, docusate sodium,  exemestane, ezetimibe and melatonin for an unknown indication, who experienced the serious (medically significant) unexpected event deafness neurosensory (reported as sensorineural hearing loss) and the non-serious event of tinnitus. Patient did not experience similar adverse events in the past and there were no other potential causes for adverse events. The event deafness neurosensory occurred 3 months after receiving the first a dose of mRNA-1273 vaccine and 2 months after receiving the second dose of mRNA-1273 vaccine. The event tinnitus 2 months after receiving the first a dose of mRNA-1273 vaccine and 1.5 weeks after receiving the second dose of mRNA-1273 vaccine. Relevant diagnostic tests included a type A tympanogram showing WRS 100% bilateral. Ear, nose, and throat examination demonstrated a bilateral sensorineural hearing loss. The outcome of the event deafness neurosensory was reported as unknown. The event tinnitus was reported as not resolved.  No treatment medications were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2023-718642:Master case US-MODERNATX, INC.-MOD-2023-718642:Master case.