Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Hearing change/sloping to severe to profound sensorineural hearing loss (right ear); Right Tinnitus with vertigo; Right Tinnitus with vertigo; This literature-non-study case was reported in a literature article and describes the occurrence of DEAFNESS NEUROSENSORY (Hearing change/sloping to severe to profound sensorineural hearing loss (right ear)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.       It was unknown if the patient was ever been diagnosed with or tested positive for COVID-19.  Concurrent medical conditions included Allergic reaction to analgesics (morphine), Sulfonamide allergy (sulfa), Back pain, Hyperlipidemia, Hypertension, Psoriasis and Ulcerative colitis. Concomitant products included CLOBETASOL, FLUTICASONE PROPIONATE (FLOVENT), DIHYDROERGOCRISTINE, LOMIFYLLINE (ANTIVERT [DIHYDROERGOCRISTINE;LOMIFYLLINE]), MELOXICAM (MOBIC), MESALAZINE (CANASA), VITAMINS NOS (MVI [VITAMINS NOS]) and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced VERTIGO (Right Tinnitus with vertigo) and TINNITUS (Right Tinnitus with vertigo). On 25-Feb-2021, the patient experienced DEAFNESS NEUROSENSORY (Hearing change/sloping to severe to profound sensorineural hearing loss (right ear)) (seriousness criterion medically significant). At the time of the report, DEAFNESS NEUROSENSORY (Hearing change/sloping to severe to profound sensorineural hearing loss (right ear)) and TINNITUS (Right Tinnitus with vertigo) was resolving and VERTIGO (Right Tinnitus with vertigo) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Audiogram: Severe rising to moderately severe, sloping to severe to profound sensorineural hearing loss. On 21-May-2021, Cerebral small vessel ischaemic disease: minimal burden of chronic small vessel ischemic disease. On 21-May-2021, Magnetic resonance imaging head: The left vertebral artery was tortuous and abuts the left cranial nerve 7/8 complex. Borderline high riding right jugular bulb. Minimal burden of chronic small vessel ischemic disease..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VERTIGO (Right Tinnitus with vertigo) and TINNITUS (Right Tinnitus with vertigo) to have an unknown relationship. No further causality assessment was provided for DEAFNESS NEUROSENSORY (Hearing change/sloping to severe to profound sensorineural hearing loss (right ear)).    The patients who received a COVID-19 vaccine in the time frame of 01-Dec-2020 to 31-Dec-2021 were included. The patients ranged in age from 41 to 84 years. Sixteen received the Pfizer vaccine, seven received the Moderna vaccine and four patients received the Janssen vaccine.   The 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 otolaryngologists.   Author stated 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.  The events caused the patient to seek for medical care (doctor's office or urgent care visit). There were no potential causes of the events and the patient did not experience a similar events in the past.  The patient was treated with oral steroids with improvement in hearing and tinnitus.  Company comment: This literature non-study case concerns a 66-year-old female patient with no relevant reported medical history, who experienced the serious (medically significant) unexpected event of Deafness neurosensory (reported as Hearing change/sloping to severe to profound sensorineural hearing loss (right ear)), non-serious unexpected events of Tinnitus and Vertigo after receiving the first dose of mRNA-1273 vaccine. It was reported that patient had tinnitus and vertigo about 8 days after vaccination for which the patient sought medical care. She was treated with oral steroids with improvement in hearing and tinnitus. About 5 days later audiogram done showed, severe rising to moderately severe, sloping to severe to profound sensorineural hearing loss. Magnetic resonance imaging head done about 3 months later showed left vertebral artery tortuous and abuts the left cranial nerve 7/8 complex. Borderline high riding right jugular bulb. Minimal burden of chronic small vessel ischemic disease. No further information was available in the report for medical review. Patient had received second dose of mRNA-1273 about 28 days after first dose followed by third dose after 8 months. 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 was received on 02-May-2023 and contains significant information: Primary reporter phone number, patient demographic details (patient initials, gender, DOB, age, height, weight, ethnicity, and race), current medical condition, lab data, vaccination details (dose number and vaccination dates), concomitant medication, additional new event, treatment details and onset date for the event tinnitus and vertigo were added. Action taken and re-challenge with vaccine, coding term of event, outcome of the events and reporter causality were updated. This case was upgraded from non-serious to serious.; Sender's Comments: This literature non-study case concerns a 66-year-old female patient with no relevant reported medical history, who experienced the serious (medically significant) unexpected event of Deafness neurosensory (reported as Hearing change/sloping to severe to profound sensorineural hearing loss (right ear)), non-serious unexpected events of Tinnitus and Vertigo after receiving the first dose of mRNA-1273 vaccine. It was reported that patient had tinnitus and vertigo about 8 days after vaccination for which the patient sought medical care. She was treated with oral steroids with improvement in hearing and tinnitus. About 5 days later audiogram done showed, severe rising to moderately severe, sloping to severe to profound sensorineural hearing loss. Magnetic resonance imaging head done about 3 months later showed left vertebral artery tortuous and abuts the left cranial nerve 7/8 complex. Borderline high riding right jugular bulb. Minimal burden of chronic small vessel ischemic disease. No further information was available in the report for medical review. Patient had received second dose of mRNA-1273 about 28 days after first dose followed by third dose after 8 months. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2023-718642:Master case (Cluster case)