Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Deafness, Dizziness, Dry mouth, Head discomfort
Clinical narrative: A pressure on the right side of head; Vestibular symptoms on the right side; Buzziness vibration; Major episode of vertigo; Dry mouth/Lost saliva; Dizziness; Lost hearing; nervous system is damaged/terrible neurological effects; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS (Lost hearing) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 036A21A and 012M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu like symptoms (20 years ago). Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included Vaccination adverse reaction with Flu vaccine. Concurrent medical conditions included Sulfonamide allergy.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced DEAFNESS (Lost hearing) (seriousness criterion medically significant) and NERVOUS SYSTEM DISORDER (nervous system is damaged/terrible neurological effects). On an unknown date, the patient experienced HEAD DISCOMFORT (A pressure on the right side of head), VESTIBULAR DISORDER (Vestibular symptoms on the right side), TINNITUS (Buzziness vibration), VERTIGO (Major episode of vertigo), DRY MOUTH (Dry mouth/Lost saliva) and DIZZINESS (Dizziness). The patient was treated with PREDNISONE for Dry mouth and Saliva decreased, at a dose of 60mg. At the time of the report, DEAFNESS (Lost hearing), NERVOUS SYSTEM DISORDER (nervous system is damaged/terrible neurological effects), HEAD DISCOMFORT (A pressure on the right side of head), VESTIBULAR DISORDER (Vestibular symptoms on the right side) and TINNITUS (Buzziness vibration) outcome was unknown and VERTIGO (Major episode of vertigo), DRY MOUTH (Dry mouth/Lost saliva) and DIZZINESS (Dizziness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: Negative. On an unknown date, Magnetic resonance imaging: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient reported lost hearing very soon after, within days of the first dose started getting 30 seconds here and there of hearing that would go out in right ear and then an episode of vertigo at the same time simultaneously. After the second dose it started happening a little bit more. After third dose it got even more frequent with major episode of vertigo, hearing went out for over 24 hours and then it never came back, 80 percent of hearing in right ear.  Patient had neurologic episode where head felt like it was vibrating inside as if patient had 3 glasses of wine. Patient had two MRI's and two CAT scans. Patient went two different EENT and they said it was nothing they can do to confirm or deny the etiology. Patient reported HCP prescribed Ativan which  did not pick up because patient does not want to take medicine or .  Company Comment: This spontaneous case concerns an adult female patient of unknown age with medical history of reaction to the flu vaccine in the past and Sulfonamide allergy reported, who experienced the unexpected serious (Medically significant) event of Deafness that occurred after first dose of mRNA-1273 vaccination in covid -19 vaccination series. Latency cannot be assessed since onset date of event was not disclosed. It was reported that patient lost hearing, terrible neurological effects within days after first dose. It was on and off associated with episodes of vertigo. After the second dose it started happening a little bit more. After third dose it got even more frequent. Then a major episode of vertigo, hearing went out for over 24 hours and then it never came back, 80% of hearing in right ear. It was reported that a neurologic thing happened where head feels like its vibrating, Vestibular symptoms on the right side and pressure on the right side of head. Two MRI's and CT scans done were with negative results. She also has dry mouth/ lost saliva. Treated with prednisone of 60mg for one month. She consulted neurologists and ENT surgeons.  No further information on investigations results, definitive diagnosis, treatment and outcome details was available in the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  This case was linked to US-MODERNATX, INC.-MOD-2023-714604 (E2B Linked Report).; Sender's Comments: This spontaneous case concerns an adult female patient of unknown age with medical history of reaction to the flu vaccine in the past and Sulfonamide allergy reported, who experienced the unexpected serious (Medically significant) event of Deafness that occurred after first dose of mRNA-1273 vaccination in covid -19 vaccination series. Latency cannot be assessed since onset date of event was not disclosed. It was reported that patient lost hearing, terrible neurological effects within days after first dose. It was on and off associated with episodes of vertigo. After the second dose it started happening a little bit more. After third dose it got even more frequent. Then a major episode of vertigo, hearing went out for over 24 hours and then it never came back, 80% of hearing in right ear. It was reported that a neurologic thing happened where head feels like its vibrating, Vestibular symptoms on the right side and pressure on the right side of head. Two MRI's and CT scans done were with negative results. She also has dry mouth/ lost saliva. Treated with prednisone of 60mg for one month. She consulted neurologists and ENT surgeons.  No further information on investigations results, definitive diagnosis, treatment and outcome details was available in the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2023-714604:Same reporter