Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Fall, Hypoacusis, Meniere's disease, Mental impairment
Clinical narrative: came back like vertigo and Meniere's disease; Mind draws a blank; Vertigo; Fell down the stairs; Problem with the ears; Sometimes she can't hear, sometimes it clears up; Body is not absorbing Vitamin B-12; This spontaneous case was reported by a consumer and describes the occurrence of MENIERE'S DISEASE (came back like vertigo and Meniere's disease) and MENTAL IMPAIRMENT (Mind draws a blank) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C217 and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo. Concurrent medical conditions included Meniere's disease and Cholesterol. Concomitant products included PRAVASTATIN for Cholesterol, MECLOZINE HYDROCHLORIDE (MECLIZINE [MECLOZINE HYDROCHLORIDE]) and CLONAZEPAM for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENIERE'S DISEASE (came back like vertigo and Meniere's disease) (seriousness criterion medically significant), MENTAL IMPAIRMENT (Mind draws a blank) (seriousness criterion medically significant), VERTIGO (Vertigo), FALL (Fell down the stairs), EAR DISCOMFORT (Problem with the ears), HYPOACUSIS (Sometimes she can't hear, sometimes it clears up) and VITAMIN B12 DEFICIENCY (Body is not absorbing Vitamin B-12). At the time of the report, MENIERE'S DISEASE (came back like vertigo and Meniere's disease), MENTAL IMPAIRMENT (Mind draws a blank), VERTIGO (Vertigo), FALL (Fell down the stairs), EAR DISCOMFORT (Problem with the ears), HYPOACUSIS (Sometimes she can't hear, sometimes it clears up) and VITAMIN B12 DEFICIENCY (Body is not absorbing Vitamin B-12) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  This case concerns a 75-year-old female patient with relevant medical history of Vertigo and Meniere's disease, who experienced the unexpected events of Meniere's Disease and Mental Impairment. The event, which was medically significant occurred on an unknown interval after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since date of occurrence of events were not disclosed. The medical history of Vertigo and Meniere's disease remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 75-year-old female patient with relevant medical history of Vertigo and Meniere's disease, who experienced the unexpected events of Meniere's Disease and Mental Impairment. The event, which was medically significant occurred on an unknown interval after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since date of occurrence of events were not disclosed. The medical history of Vertigo and Meniere's disease remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.