Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Audiogram, Deafness neurosensory, Tinnitus
Clinical narrative: Left ear increase in tinnitus and hearing loss/bilateral downsloping SNHL; Left ear increase in tinnitus; This literature-non-study case was reported in a literature article and describes the occurrence of DEAFNESS NEUROSENSORY (Left ear increase in tinnitus and hearing loss/bilateral downsloping SNHL) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.       The patient's past medical history included COVID-19 on 03-Jan-2021. Concurrent medical conditions included Hypertension, Hyperlipidemia since 31-Dec-2014, Drug allergy (Allergic to Aldosterone antagonist), Heart murmur and Tinnitus. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]), FUROSEMIDE (LASIX [FUROSEMIDE]), GABAPENTIN and GLUCOSAMINE for an unknown indication.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced DEAFNESS NEUROSENSORY (Left ear increase in tinnitus and hearing loss/bilateral downsloping SNHL) (seriousness criterion medically significant) and TINNITUS (Left ear increase in tinnitus). At the time of the report, DEAFNESS NEUROSENSORY (Left ear increase in tinnitus and hearing loss/bilateral downsloping SNHL) and TINNITUS (Left ear increase in tinnitus) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2021, Audiogram: Audio right ear results: mild to severe sensorineural hearing loss with very poor word recognition at MCL. On 09-Sep-2021, Audiogram: Audio test: This demonstrates a bilateral downsloping sensorineural hearing loss, word recognition score 32% on left, 52% on right..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DEAFNESS NEUROSENSORY (Left ear increase in tinnitus and hearing loss/bilateral downsloping SNHL) and TINNITUS (Left ear increase in tinnitus) to have an unknown relationship.    Concomitant medications were reported as JS Sulfate. Treatment medications were not reported.  Patient had CT of head in 2020 and impressions were reported as: 1. Diffuse atrophy and chronic white matter disease with remote left temporal parietal infraction; 2. No acute intracranial process. 3. Right sphenoid sinus disease.  Patient visited ENT and experienced local sudden hearing loss in the left ear. Patient had existing tinnitus that was increased in the left ear on 19-may-2021. It was reported that there were no other potential causes for adverse events and patient did not experience similar adverse events in the past.  ENT on 29-07-2021.  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 spontaneous case report concerns a 79-year-old male patient with relevant medical history of Tinnitus in the left ear and previous COVID-19 infection, who experienced serious (medically significant) unexpected event of Deafness neurosensory, as well as non serious unexpected event if Tinnitus. Reportedly, 14 days after the patient had received the first dose of the mRNA-1273 vaccine, he developed sudden hearing loss in this left ear. In addition, it was stated that tinnitus in his left ear increased, as well. Audiogram, that was performed 2 months and one week following this vaccination, showed mild to severe sensorineural hearing loss with very poor word recognition at most comfortable loudness level in the right ear. Furthermore, approximately four months after this vaccination, an audiogram showed bilateral downsloping sensorineural hearing loss with word recognition score 32% on left and 52% on right. No treatments were recorded. At the time of this report, the events were still ongoing. The patient's elderly age is considered as significant confounding factor. In addition, medical history of Tinnitus remains a confounder for the aggravation of Tinnitus. The reporter's causality assessment was reported as unknown. No further details were available for medical assessment. 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 ( Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2023: Follow up received by safety on 21-Apr-2023 has Email contains Non significant information:  Reporter details updated. On 02-May-2023: Follow-up received by safety on 03-May-2023 has an email with ADR form and contains significant information. Reporter information, patient details, medical history, lab data, suspect details, concomitant medications and event details were updated.; Sender's Comments: This spontaneous case report concerns a 79-year-old male patient with relevant medical history of Tinnitus in the left ear and previous COVID-19 infection, who experienced serious (medically significant) unexpected event of Deafness neurosensory, as well as non serious unexpected event if Tinnitus. Reportedly, 14 days after the patient had received the first dose of the mRNA-1273 vaccine, he developed sudden hearing loss in this left ear. In addition, it was stated that tinnitus in his left ear increased, as well. Audiogram, that was performed 2 months and one week following this vaccination, showed mild to severe sensorineural hearing loss with very poor word recognition at most comfortable loudness level in the right ear. Furthermore, approximately four months after this vaccination, an audiogram showed bilateral downsloping sensorineural hearing loss with word recognition score 32% on left and 52% on right. No treatments were recorded. At the time of this report, the events were still ongoing. The patient's elderly age is considered as significant confounding factor. In addition, medical history of Tinnitus remains a confounder for the aggravation of Tinnitus. The reporter's causality assessment was reported as unknown. No further details were available for medical assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2023-718642:Master case (Cluster case CW)