Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Dizziness, Gait disturbance, Hypoacusis
Clinical narrative: Dizzy after 2nd shot; Debilitating after 2nd shot; Loss of balance after 2nd shot; Can not take a shower on his own after 2nd shot; Walks around with a Cane after 2nd shot; Hearing is worst after 2nd shot; Vertigo after 2nd shot; Vision is worst after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy after 2nd shot), ASTHENIA (Debilitating after 2nd shot), BALANCE DISORDER (Loss of balance after 2nd shot), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can not take a shower on his own after 2nd shot), GAIT DISTURBANCE (Walks around with a Cane after 2nd shot), HYPOACUSIS (Hearing is worst after 2nd shot) and VERTIGO (Vertigo after 2nd shot) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anemia.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced DIZZINESS (Dizzy after 2nd shot) (seriousness criterion hospitalization), ASTHENIA (Debilitating after 2nd shot) (seriousness criterion hospitalization), BALANCE DISORDER (Loss of balance after 2nd shot) (seriousness criterion hospitalization), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can not take a shower on his own after 2nd shot) (seriousness criterion hospitalization), GAIT DISTURBANCE (Walks around with a Cane after 2nd shot) (seriousness criterion hospitalization), HYPOACUSIS (Hearing is worst after 2nd shot) (seriousness criterion hospitalization), VERTIGO (Vertigo after 2nd shot) (seriousness criterion hospitalization) and VISUAL IMPAIRMENT (Vision is worst after 2nd shot). At the time of the report, DIZZINESS (Dizzy after 2nd shot), ASTHENIA (Debilitating after 2nd shot), BALANCE DISORDER (Loss of balance after 2nd shot), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can not take a shower on his own after 2nd shot), GAIT DISTURBANCE (Walks around with a Cane after 2nd shot), HYPOACUSIS (Hearing is worst after 2nd shot), VERTIGO (Vertigo after 2nd shot) and VISUAL IMPAIRMENT (Vision is worst after 2nd shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. Treatment details include Medication for Vertigo.  The patient had to get new hearing aids" and  "had to get new eye glasses  Company Comment: This case concerns a 84-year-old male patient with medical history of anemia, who experienced the unexpected events of dizziness, asthenia, balance disorder, loss of personal independence in daily activities, gait disturbance, hypoacusis and vertigo. The events occurred on the same day after the second dose of Spikevax. The rechallenge is not applicable. The medical history of anemia remains as a confounder. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-326063 (Patient Link).; Sender's Comments: This case concerns a 84-year-old male patient with medical history of anemia, who experienced the unexpected events of dizziness, asthenia, balance disorder, loss of personal independence in daily activities, gait disturbance, hypoacusis and vertigo. The events occurred on the same day after the second dose of Spikevax. The rechallenge is not applicable. The medical history of anemia remains as a confounder. The benefit-risk relationship of Spikevax is not affected by this report.