Sex: U
Vaccine: COVID19
Symptoms: Cerumen impaction, Deafness neurosensory, Fatigue, Headache, Injection site pain
Clinical narrative: sensorineural hearing loss; Benign paroxysmal positional vertigo; Cerumen impaction; Temporomandibular joint DISORDER; Presbycusis; INJECTION SITE PAIN; FEVER; FATIGUE; MYALGIA; HEADACHE; This solicited report received from a physician by COV19VAC-NONCOMP: Jansen COVID 19 Non Company Solicited Study. This report was referenced in literature: and concerned a patient of unspecified age and sex (subject number and site number were not reported). The patients height and weight were not reported. Age at time of vaccination was unknown. Aim- Anecdotal reports of sudden sensorineural hearing loss (SSNHL) following COVID-19 vaccination have emerged in the otolaryngology community. Studies have demonstrated no association between COVID-19 vaccination and SSNHL. We aim to characterize the spectrum of otologic symptoms following COVID-19 vaccination.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patients received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up.  No concomitant medications were reported.  Methods- Patients presenting to the otology clinic at a tertiary care, urban medical center between May and July 2021 were screened with a short questionnaire for development of otologic symptoms following COVID-19 vaccination. Patients were  inquired about  previous COVID-19 infection, method and date of diagnosis if previously infected, COVID- 19  vaccination status,  and  vaccine brand  and  dates  if  vaccinated. Screened symptoms included hearing loss,  tinnitus, ear  drainage, dizziness, vertigo, imbalance, facial nerve palsy, smell change, and taste change; patients were specifically asked if such symptoms appeared during active COVID-19 infection or within 4 weeks of any dose of COVID-19 vaccination. Additionally, demographic data, including age and gender, were obtained. All above uses of patient data were approved by the Regulatory Authority. For patients reporting any otologic symptoms, a retrospective chart review was performed to collect audiometric data and final diagnoses. Audiometric data from the initial presentation were gathered and notes written by the primary otologist were reviewed for relevant medical history, diagnoses, and treatments. Pearson's chi-square test was used to evaluate for significant differences in vaccination proportions. On an unspecified date, the patients experienced sensorineural hearing loss, benign paroxysmal positional vertigo, cerumen impaction, temporomandibular joint disorder, presbycusis, injection site pain, fever, fatigue, myalgia, and headache. Dose series 1. Results- Between May and July 2021, 500 patients were screened. Median age was 56.6 years old, with 59.4 % female and 40.2 % male. 420 patients (84.0 %) were vaccinated, with 58.4 % receiving Pfizer, 29.1 % receiving Moderna, and 3.8 % receiving Johnson & Johnson. 61 patients (14.5 %) reported one or more otologic symptoms within 4 weeks of vaccination, including 21 (5.0 %) with hearing loss, 26 (6.2 %) with tinnitus, 33 (7.9 %) with dizziness, and 19 (4.5 %) with vertigo. Of the 16 patients (3.2 %) reporting tinnitus with no associated hearing loss, 8 were diagnosed with subjective tinnitus and 4 were diagnosed with temporomandibular joint syndrome. Of the 18 patients reporting hearing loss, 11 had exacerbations of underlying pathologies (e.g. Meniere's disease, presbycusis) and 7 were newly diagnosed with SSNHL (1.4 %). The action taken with janssen covid-19 vaccine was not applicable.  The outcome of sensorineural hearing loss, benign paroxysmal positional vertigo, cerumen impaction, temporomandibular joint disorder, presbycusis, injection site pain, fever, fatigue, myalgia and headache was not reported.  The reporter considered the causality between janssen covid-19 vaccine and sensorineural hearing loss, benign paroxysmal positional vertigo, cerumen impaction, temporomandibular joint disorder, presbycusis, injection site pain, fever, fatigue, myalgia, and headache as not reported. Company causality between janssen covid-19 vaccine and Vertigo positional, Cerumen impaction, Temporomandibular pain and dysfunction syndrome, Presbyacusis, sensorineural hearing loss, injection site pain, fever, fatigue, myalgia, and headache was not related. Conclusion- Patients reporting otologic symptoms following COVID-19 vaccination received various diagnoses of uncertain etiology. The incidence of SSNHL in these patients is comparable to the general otology patient population. Additional studies are  required to  determine the  incidence of  specific diagnoses following vaccination.    This report was serious (other medically important condition).; Sender's Comments: V0-Deafness neurosensory, Vertigo positional, Cerumen impaction,  Temporomandibular pain and dysfunction syndromePresbyacusis. 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.