Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Audiogram, Deafness neurosensory, Ear, nose and throat examination, Tinnitus
Clinical narrative: NORMAL TO MILD SENSORINEURAL HEARING LOSS BILATERALLY; LEFT EAR TINNITUS; This spontaneous report was received from literature. This report was also received from a consumer via social media (media) via another pharmaceutical company (Pfizer). This report concerned a 58 year old male. The objective of this study was to describe cases of tinnitus after COVID-19 vaccination mainly to raise awareness of this possibility and prompt referral for audiology and otolaryngology evaluation for possible concurrent sudden sensorineural hearing loss and treatment as appropriate. The patient's height, and weight were not reported. The patient's past medical history included: hyperuricemia, and urinary calculus, and concurrent conditions included: adenomatous polyp of colon, allergic rhinitis, hyperglycemia, hyperlipidemia, and tinnitus, and other pre-existing medical conditions included: Patient had family history of colon cancer, diabetes mellitus, hypertension (13-AUG-2014), and Ischemic heart Disease,  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, and batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on 03-MAY-2021 for covid-19 prophylaxis. Age at time of vaccination 58 years old. The batch number was not reported and has been requested. Concomitant medications included acetylsalicylic acid, ascorbic acid/dexpanthenol/ergocalciferol/nicotinamide/pyridoxine hydrochloride/retinol palmitate/riboflavin sodium phosphate/thiamine hydrochloride/tocopheryl acetate, chondroitin sulfate sodium/glucosamine hydrochloride/manganese gluconate/sodium borate decahydrate, colchicine, fish oil, ibuprofen, and mometasone furoate. This study involved 27 patients out of which 4 patients received JANSSEN COVID-19 VACCINE. The patients ranged in age from 41 to 84 years old including seven male and twenty female patients. Patients were included if they are having possible covid vaccine related tinnitus and reported tinnitus onset within four weeks of any COVID-19 vaccine dose, no other attributable cause were identified, had an audiogram after onset of symptoms and at least one visit with our Otolaryngologists. On 03-MAY-2021, 25 minutes after vaccination, the patient experienced left ear tinnitus (described it as high-pitched constant ring). On 22-JUL-2021, Laboratory data included: Ear, nose and throat examination (Eval left ear) showed high pitched constant eval with ENT (ear nose tongue). Laboratory data (dates unspecified) included: Audiogram as Not reported, and an Audiogram which showed normal to mild SNHL (Sensorineural hearing loss) bilaterally. On an unspecified date, the patient experienced normal to mild sensorineural hearing loss bilaterally. The patient did not had vertigo and no treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left ear tinnitus and normal to mild sensorineural hearing loss bilaterally was not reported. The authors concluded that there is no definite correlation could be established between covid-19 vaccine and tinnitus 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. In cases of sudden hearing loss, treatment with oral and/or intratympanic steroids within the recommended time frame should be considered based on prior clinical practice guidelines as causation by COVID-19 vaccination has not been proven. Improvement in tinnitus after steroids is not clearly shown and providers should use their discretion in each individual case. This report was serious (Other Medically Important Condition). This case, from Same Literature article is linked to 20230410678, 20230424639 and 20230424648.  This case was reassessed as serious based on additional information received from health care professional on 05-JUN-2023, the following information was updated and incorporated into case narrative: Added patient demographics (DOB, age at the time of event and vaccination), therapy details, medical history and concomitant medications, updated event term from tinnitus to left ear tinnitus, added event onset date (left ear tinnitus), latency, added additional event of normal to mild sensorineural hearing loss bilaterally, updated seriousness of case.; Sender's Comments: V2: This case was reassessed as serious based on additional information received from health care professional and the following information was updated- additional serious event of normal to mild sensorineural hearing loss bilaterally, patient demographics (DOB, age at the time of event and vaccination), therapy details, medical history and concomitant medications, updated event term from tinnitus to left ear tinnitus, added event onset date (left ear tinnitus), latency. 20230427728- Normal to mild sensorineural hearing loss bilaterally. Follow-up received regarding Clinical Details. 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 unassessable.