Received Jun 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
worsening of autoimmune inner ear disease (AIED)/ asymmetric flat hearing loss; worsening of autoimmune inner ear disease (AIED)/ asymmetric flat hearing loss; Unilateral hearing loss; This literature-non-study case was reported in a literature article and describes the occurrence of AUTOIMMUNE INNER EAR DISEASE (worsening of autoimmune inner ear disease (AIED)/ asymmetric flat hearing loss), CONDITION AGGRAVATED (worsening of autoimmune inner ear disease (AIED)/ asymmetric flat hearing loss) and DEAFNESS UNILATERAL (Unilateral hearing loss) in a 51-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. LITERATURE REFERENCE: Concurrent medical conditions included Autoimmune inner ear disease. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE INNER EAR DISEASE (worsening of autoimmune inner ear disease (AIED)/ asymmetric flat hearing loss) (seriousness criterion medically significant), CONDITION AGGRAVATED (worsening of autoimmune inner ear disease (AIED)/ asymmetric flat hearing loss) (seriousness criterion medically significant) and DEAFNESS UNILATERAL (Unilateral hearing loss) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE INNER EAR DISEASE (worsening of autoimmune inner ear disease (AIED)/ asymmetric flat hearing loss), CONDITION AGGRAVATED (worsening of autoimmune inner ear disease (AIED)/ asymmetric flat hearing loss) and DEAFNESS UNILATERAL (Unilateral hearing loss) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Audiogram: prior audiograms were available to confirm the acute change in hearing that was temporally related to COVID-19 exposure and audiometric confirmation of an asymmetric hearing loss. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered AUTOIMMUNE INNER EAR DISEASE (worsening of autoimmune inner ear disease (AIED)/ asymmetric flat hearing loss), CONDITION AGGRAVATED (worsening of autoimmune inner ear disease (AIED)/ asymmetric flat hearing loss) and DEAFNESS UNILATERAL (Unilateral hearing loss) to be related. Concomitant medications were not reported. The patient had asymmetric flat hearing loss post vaccination. The hearing loss was related to vaccine. The patient had previous hearing decline unrelated to vaccine. There was no hearing recovery with steroids. Reported that immune-mediated hearing loss (IMHL) patients (comprised of autoimmune inner ear disease (AIED) and sudden sensorineural hearing loss (SSNHL)) may be at higher risk for hearing loss following Coronavirus disease (COVID-19) infection and/or vaccination. This study compared inflammatory cytokine expression in response to SARS-CoV2 spike protein between two groups of patients with IMHL: IMHL patients that temporally demonstrated worsening SNHL following COVID vaccination or infection as compared to IMHL patients with worsening SNHL unrelated to COVID exposure: (IMHL-COVID (?+)) (n?=?11) (IMHL-COVID (-)) (n?=?10). Two groups, treated isolated PBMCs with increasing amounts of SARS-CoV-2 spike protein and compared responses to stimulation with positive and negative controls. IMHL-COVID (+) group is further broken down into 6 patients with AIED that experienced prior hearing declines over a several year period prior to COVID-19 exposure and 5 patients with SSNHL temporally related to COVID-19 exposure with no prior history of acute hearing loss. Patients were enrolled at the time of their office visit reporting a decline in hearing, and blood was collected if audiometric confirmation of an asymmetric hearing loss was obtained. All patients were queried as to COVID-19 exposure, COVID-19 vaccination history, and hearing health history of IMHL which included prior diagnoses of SSNHL, AIED or Meniere's Disease. The hearing losses all occurred between 2021 and 2023. All patients had PBMC harvested immediately prior to the institution of corticosteroid therapy. The time interval between the index event of perceived loss and clinical evaluation and enrollment was highly variable, from 1 day to several months, however the perceived hearing change had to have occurred within a two-week period following infection/vaccination to be considered for enrollment. Informed consent was provided by all enrolled patients prior to entering a subject into the study. Peripheral Blood Mononuclear Cells (PBMC) from IMHL-COVID (?+) patients had increased expression and release of both IL-1ß and IL-6 in response to spike protein as compared to IMHL-COVID (-) patients. However, when the IMHL-COVID (?+) group was broken down into AIED patients compared to SSNHL, it became apparent that the greatest responses were from the AIED patients. When reporter broke down the COVID (?+) group to infection versus vaccination, the immune responses in the infection group (N?=?3 AIED, 1 SSNHL) were stronger. SARS-CoV-2 spike protein at 12 µg/ml concentration showed robust release of IL-6 in infection group (around sixfold) when compared to the vaccination group. SARS-CoV-2 spike protein showed dose-dependent release of IL-1Ra in both groups. Spike protein at 12 µg/ml concentration showed much greater release of IL-1Ra in infection group when compared to the vaccination group This study concluded that COVID-19 exposure with reported changes in hearing sensitivity in IMHL patients resulted in pro-inflammatory responses in response to spike protein. The inflammatory responses were greatest in AIED patients, and greater following infection rather than vaccination. This case was linked to US-MODERNATX, INC.-MOD-2025-786805 (E2B Linked Report).; Reporter's Comments: Patients underlying condition of Autoimmune inner ear disease is a risk factor for the events. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786805:61-Year-old Female patient (Same Report)
Autoimmune inner ear disease
Test Name: Audiogram; Result Unstructured Data: prior audiograms were available to confirm the acute change in hearing that was temporally related to COVID-19 exposure; Test Name: Audiometric test; Result Unstructured Data: audiometric confirmation of an asymmetric hearing loss