Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Otitis media acute, Otorrhoea, Otosclerosis, Presbyacusis, Pruritus
Clinical narrative: EXACERBATIONS OF COCHLEAR HYDROPS; CONDUCTIVE HEARING LOSS OF UNKNOWN ORIGIN; MENIERE'S DISEASE; IDIOPATHIC SUDDEN SENSORINEURAL HEARING LOSS; CSF LEAK; VESTIBULAR SCHWANNOMA; ENDOLYMPHATIC SAC TUMOUR; DIZZINESS; VERTIGO; IMBALANCE; PRESBYCUSIS; TINNITUS; EAR DRAINAGE; ACUTE OTITIS MEDIA; TEMPOROMANDIBULAR JOINT SYNDROME; CERUMEN  IMPACTION; SUBJECTIVE TINNITUS; OTOSCLEROSIS; EAR ITCH; VESTIBULAR MIGRAINE; This solicited report received from a health care professional via Study by a Regulatory Authority on 18-JAN-2024 was received on 19-JAN-2024 and concerned multiple patients. This patients were also referenced in literature. The patients' weight, height, and medical history were not reported.  No past medical history or concurrent conditions were reported. The patients received vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. Non-company suspect vaccine included: tozinameran (form of admin, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. ; and elasomeran (form of admin, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. Batch number was not reported. We are unable to perform follow-up to request the batch numbers. No concomitant medications were reported. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2., the patient experienced exacerbations of cochlear hydrops, conductive hearing loss of unknown origin, meniere's disease, idiopathic sudden sensorineural hearing loss, csf leak, vestibular schwannoma, endolymphatic sac tumour, dizziness, vertigo, imbalance, presbycusis, tinnitus, ear drainage, acute otitis media, temporomandibular joint syndrome, cerumen impaction, subjective tinnitus, otosclerosis, ear itch, and vestibular migraine (Dose number in series 1). Treatment medications (dates unspecified) included: prednisone, and dexamethasone. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran, and elasomeran was not applicable. The outcome of the dizziness, vertigo, idiopathic sudden sensorineural hearing loss, imbalance, presbycusis, tinnitus, ear drainage, csf leak, vestibular schwannoma, acute otitis media, temporomandibular joint syndrome, cerumen impaction, endolymphatic sac tumour, subjective tinnitus, otosclerosis, ear itch, vestibular migraine, exacerbations of cochlear hydrops, conductive hearing loss of unknown origin and meniere's disease was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and exacerbations of cochlear hydrops, conductive hearing loss of unknown origin, meniere's disease, idiopathic sudden sensorineural hearing loss, csf leak, vestibular schwannoma, endolymphatic sac tumour, dizziness, vertigo, imbalance, presbycusis, tinnitus, ear drainage, acute otitis media, temporomandibular joint syndrome, cerumen impaction, subjective tinnitus, otosclerosis, ear itch, and vestibular migraine as related. The reporter did not provide a causality assessment between tozinameran, and exacerbations of cochlear hydrops, conductive hearing loss of unknown origin, meniere's disease, idiopathic sudden sensorineural hearing loss, csf leak, vestibular schwannoma, endolymphatic sac tumour, dizziness, vertigo, imbalance, presbycusis, tinnitus, ear drainage, acute otitis media, temporomandibular joint syndrome, cerumen impaction, subjective tinnitus, otosclerosis, ear itch, and vestibular migraine; and between elasomeran, and exacerbations of cochlear hydrops, conductive hearing loss of unknown origin, meniere's disease, idiopathic sudden sensorineural hearing loss, csf leak, vestibular schwannoma, endolymphatic sac tumour, dizziness, vertigo, imbalance, presbycusis, tinnitus, ear drainage, acute otitis media, temporomandibular joint syndrome, cerumen impaction, subjective tinnitus, otosclerosis, ear itch, and vestibular migraine. Company causality between covid-19 vaccine ad26.cov2.s, and exacerbations of cochlear hydrops, conductive hearing loss of unknown origin, meniere's disease, idiopathic sudden sensorineural hearing loss, csf leak, vestibular schwannoma, endolymphatic sac tumour, dizziness, vertigo, imbalance, presbycusis, ear drainage, acute otitis media, temporomandibular joint syndrome, cerumen impaction, otosclerosis, ear itch, and vestibular migraine was not related.  The authors commented that nearly all patients (6/7) diagnosed with [idiopathic sudden sensorineural hearing loss] following COVID-19 vaccination were treated with steroid therapy, in the form of intratympanic dexamethasone or oral prednisone. Of these patients, 4 were eventually referred for cochlear implantation due to the degree of hearing loss and lack of improvement. They attributed tinnitus and [temporomandibular joint] syndrome following vaccination to increased physical and emotional stress, although acute inflammatory processes producing otologic symptoms cannot be ruled. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; Endolymphatic hydrops, Conductive deafness, Meniere's disease,  Cerebrospinal fluid leakage, Acoustic neuroma, Deafness neurosensory, Tumor. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered not related.