Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Ocular discomfort, Quality of life decreased, Vision blurred, Visual impairment
Clinical narrative: Dizziness really hit him; Got dizzy because of the frustration and aggravation; Couldn't walk nor drive /can't go to the river bunk because I feel like I might fall in; Glasses for prism correction (6)/prism went down to a 3/the prism was up to a 5./couldn't see the letters on the eye test; Felt like they were pulling his eyes out of his head; Can't function with this/I've been fighting this ever since/I can't do the things I'm used to: can't go deer hunting; Everything went blurry again because of the dizziness; Losing the quality of life because of this; Couldn't drive; high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness really hit him) 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 Tennis elbow (A surgery to reposition his nerves in the elbow (tennis elbow).), Prostate cancer, Knee replacement, Back surgery, Shoulder operation NOS, Penile implant, Prostatectomy NOS, Stent placement, Endolymphatic shunt placement and Neurosurgery (A surgery to reposition his nerves in the elbow (tennis elbow).). Concurrent medical conditions included Carpal tunnel syndrome. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), ACETYLSALICYLIC ACID (BABY ASPIRIN), CELECOXIB, GABAPENTIN, PARACETAMOL (ACETAMINOPHEN), IRON, MULTIVITAMINS [VITAMINS NOS], EVOLOCUMAB (REPATHA) and TESTOSTERONE for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 (Dizziness really hit him) (seriousness criterion hospitalization). On an unknown date, the patient experienced FRUSTRATION TOLERANCE DECREASED (Got dizzy because of the frustration and aggravation), GAIT INABILITY (Couldn't walk nor drive /can't go to the river bunk because I feel like I might fall in), VISUAL IMPAIRMENT (Glasses for prism correction (6)/prism went down to a 3/the prism was up to a 5./couldn't see the letters on the eye test), OCULAR DISCOMFORT (Felt like they were pulling his eyes out of his head), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't function with this/I've been fighting this ever since/I can't do the things I'm used to: can't go deer hunting), VISION BLURRED (Everything went blurry again because of the dizziness), QUALITY OF LIFE DECREASED (Losing the quality of life because of this), IMPAIRED DRIVING ABILITY (Couldn't drive) and HYPERTENSION (high blood pressure). The patient was hospitalized for 4 days due to DIZZINESS. At the time of the report, DIZZINESS (Dizziness really hit him), FRUSTRATION TOLERANCE DECREASED (Got dizzy because of the frustration and aggravation), GAIT INABILITY (Couldn't walk nor drive /can't go to the river bunk because I feel like I might fall in), VISUAL IMPAIRMENT (Glasses for prism correction (6)/prism went down to a 3/the prism was up to a 5./couldn't see the letters on the eye test), OCULAR DISCOMFORT (Felt like they were pulling his eyes out of his head), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't function with this/I've been fighting this ever since/I can't do the things I'm used to: can't go deer hunting), VISION BLURRED (Everything went blurry again because of the dizziness), QUALITY OF LIFE DECREASED (Losing the quality of life because of this), IMPAIRED DRIVING ABILITY (Couldn't drive) and HYPERTENSION (high blood pressure) outcome was unknown.            No treatment medication information provided.  Patient was sent to the optometrist. They gave him glasses for prism correction (6).  Past medical history also include an implant to control the excretion of urine and a bone repair on his heal.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Rechallenge could be positive as the event dizziness worsened after the second dose. However, concomitant medication with gabapentin and medical history of inner ear problems could be confounding factors for the case. Further information is expected.   This case was linked to MOD-2021-292892 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Rechallenge could be positive as the event dizziness worsened after the second dose. However, concomitant medication with gabapentin and medical history of inner ear problems could be confounding factors for the case. Further information is expected.