Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Deafness unilateral, Illness, SARS-CoV-2 test
Clinical narrative: she got very sick after both doses; extremely bad arthralgias; significant hearing loss in her left ear/couldn't hear anything out of that ear / was told that my hearing wouldn't improve; sudden uptick in symptoms; feeling vertigo; This spontaneous case was reported by a physician and describes the occurrence of DEAFNESS UNILATERAL (significant hearing loss in her left ear/couldn't hear anything out of that ear / was told that my hearing wouldn't improve) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eczema in 1975, COVID-19 in February 2020 and Vertigo (had vertigo during COVID in 2020 and vertigo went away after the infection cleared) in 2020. Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Drug allergy (Flu vaccine), Latex allergy, Allergic to cats, Penicillin allergy, Sulfonamide allergy, Allergy to plants (Aloe), Fruit allergy (Citrus), Allergy to lanolin, Pollen allergy, Dust allergy, Allergy to molds, Latex allergy (Nitrile), Hypothyroidism since 2009, Asthma (unknown, maybe 1985), Photosensitivity allergic reaction since 2002 and Multiple allergies.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VERTIGO (feeling vertigo). On 10-Oct-2021, the patient experienced CONDITION AGGRAVATED (sudden uptick in symptoms). On 11-Oct-2021, the patient experienced DEAFNESS UNILATERAL (significant hearing loss in her left ear/couldn't hear anything out of that ear / was told that my hearing wouldn't improve) (seriousness criterion medically significant). On an unknown date, the patient experienced ILLNESS (she got very sick after both doses) and ARTHRALGIA (extremely bad arthralgias). The patient was treated with PREDNISONE (oral) for Hearing loss, at an unspecified dose and frequency. At the time of the report, DEAFNESS UNILATERAL (significant hearing loss in her left ear/couldn't hear anything out of that ear / was told that my hearing wouldn't improve) and VERTIGO (feeling vertigo) had not resolved and CONDITION AGGRAVATED (sudden uptick in symptoms), ILLNESS (she got very sick after both doses) and ARTHRALGIA (extremely bad arthralgias) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2020, SARS-CoV-2 test: (Negative) later and it was negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  The physician believed she had COVID in February 2020 (unspecified date). She had all the symptoms but did not test until four weeks later and it was negative. The physician stated she got very sick after both doses of Moderna COVID-19 Vaccine recapitulating when she had COVID the first year. The patient was having extremely bad arthralgias. Around a week after the second dose, she started feeling vertigo, which was persistent. She heard on the news that some people had vertigo, so she wasn't surprised. It never went away. It tapered off and got less bad. She filed a VAERS report in May 2021(unspecified date). Then it got worse in the summer. There was a sudden uptick in symptoms around 01/Oct/2021. On 10/Oct/2021, the patient woke up suddenly at 5 AM. It sounded like someone was playing a siren in her ear. She couldn't hear anything out of that ear. It didn't go away in a couple hours, so she called an ENT physician. She had significant hearing loss in her left ear at the physician's office the next day 11/Oct/2021 that wasn't there the day before. The patient had the audiogram if needed. They treated it with oral prednisone, which she took for a week. That made a tiny difference in the audiogram. Then they gave her steroid injections closer to her ear, which didn't do anything at all. The steroids seemed to help her vertigo a lot. The patient gets vertigo reliably if she changes positions from standing to lying down. It happens every couple days for half a second. When that happens, she loses her balance, and then she'll catch herself. She was told that her hearing wouldn't improve and to go get a hearing aid. The physician thinks that during her initial COVID infection, the virus went to her ear on the left side because she also had vertigo. Then the vertigo went away after the infection cleared. She thinks it's an autoimmune effect that was triggered by the vaccine.  Company Comment: This is a spontaneous case concerning a 55-year-old, female patient with relevant medical history of vertigo and concurrent medical condition of hypothyroidism. The patient experienced the unexpected serious (medically significant) event of significant hearing loss on her left ear, the unexpected non-serious events of condition aggravated, vertigo, and illness, and the expected non-serious event of arthralgia. The patient received first and second dose of mRNA-1273 with dosage interval of 27 days. The event vertigo occurred approximately 1 week after the second dose of mRNA-1273 vaccine administration. The events condition aggravated and significant hearing loss on her left ear occurred approximately 8 months and 2 weeks after the second dose of mRNA-1273 vaccine administration. The event illness exact occurrence unknown but stated that the event occurred after the first and second dose of mRNA-1273 vaccine administration. The event arthralgia exact occurrence unknown with respect to the first and second dose of mRNA-1273 vaccine. Allegedly the events were described as, the patient got very sick after both doses of mRNA-1273 vaccine. The patient reports having extremely bad arthralgias. Around a week after the second dose, she started feeling vertigo, which was really persistent and never went away. Approximately 8 months and 2 weeks after the second dose, the patient experienced a sudden uptick in symptoms. The patient woke up really suddenly at 5 AM. It sounded like someone was playing a siren in her ear. The patient couldn't hear anything out of that ear and it didn't go away in a couple hours. The next day, the patient sought consult and audiogram was performed. It was reported that the patient has significant hearing loss in her left ear. The patient was treated with oral Prednisone and made a tiny difference in audiogram. The patient received steroid injections closer to her ear. The steroids provided relief from her vertigo. It was reported that she was told that her hearing would not improve and she needs a hearing aid. No further clinical information was available for medical review. The underlying cause of concurrent medical condition of vertigo may remain confounder for the event significant hearing loss on her left ear. The concurrent medical condition of vertigo remain confounder for the event vertigo. The concurrent medical condition of hypothyroidism remain confounder for the event arthralgia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-635903 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 55-year-old, female patient with relevant medical history of vertigo and concurrent medical condition of hypothyroidism. The patient experienced the unexpected serious (medically significant) event of significant hearing loss on her left ear, the unexpected non-serious events of condition aggravated, vertigo, and illness, and the expected non-serious event of arthralgia. The patient received first and second dose of mRNA-1273 with dosage interval of 27 days. The event vertigo occurred approximately 1 week after the second dose of mRNA-1273 vaccine administration. The events condition aggravated and significant hearing loss on her left ear occurred approximately 8 months and 2 weeks after the second dose of mRNA-1273 vaccine administration. The event illness exact occurrence unknown but stated that the event occurred after the first and second dose of mRNA-1273 vaccine administration. The event arthralgia exact occurrence unknown with respect to the first and second dose of mRNA-1273 vaccine. Allegedly the events were described as, the patient got very sick after both doses of mRNA-1273 vaccine. The patient reports having extremely bad arthralgias. Around a week after the second dose, she started feeling vertigo, which was really persistent and never went away. Approximately 8 months and 2 weeks after the second dose, the patient experienced a sudden uptick in symptoms. The patient woke up really suddenly at 5 AM. It sounded like someone was playing a siren in her ear. The patient couldn't hear anything out of that ear and it didn't go away in a couple hours. The next day, the patient sought consult and audiogram was performed. It was reported that the patient has significant hearing loss in her left ear. The patient was treated with oral Prednisone and made a tiny difference in audiogram. The patient received steroid injections closer to her ear. The steroids provided relief from her vertigo. It was reported that she was told that her hearing would not improve and she needs a hearing aid. No further clinical information was available for medical review. The underlying cause of concurrent medical condition of vertigo may remain confounder for the event significant hearing loss on her left ear. The concurrent medical condition of vertigo remain confounder for the event vertigo. The concurrent medical condition of hypothyroidism remain confounder for the event arthralgia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.