Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Foreign body sensation in eyes, Gait disturbance, Hypertension, Vision blurred, Wrong technique in product usage process
Clinical narrative: BP is high; Vaccine was jammed by the pharmacist didn't administer gently.; Can't walk/can't walk straight; Blurry vision/can't focus on her 3rd day; Dizziness; She is feeling bad feel like something is on my eye/Patient mentioned that her eye is strange; Having out of balance feeling/Her right eye doesn't coordinate .; Double vision; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Double vision), VISION BLURRED (Blurry vision/can't focus on her 3rd day), DIZZINESS (Dizziness) and FEELING ABNORMAL (She is feeling bad feel like something is on my eye/Patient mentioned that her eye is strange) in an 86-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes (Started 20 years ago.), Heart failure and Thyroid disorder NOS. Concomitant products included INSULIN, SACUBITRIL, VALSARTAN (ENTRESTO) and CARVEDILOL (COREG CR) for an unknown indication.    On 20-Sep-2023 at 4:00 PM, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In September 2023, the patient experienced DIPLOPIA (Double vision) (seriousness criterion medically significant). September 2023, the patient experienced FEELING ABNORMAL (She is feeling bad feel like something is on my eye/Patient mentioned that her eye is strange) (seriousness criterion medically significant) and BALANCE DISORDER (Having out of balance feeling/Her right eye doesn't coordinate .). On 20-Sep-2023, the patient experienced VISION BLURRED (Blurry vision/can't focus on her 3rd day) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant) and GAIT DISTURBANCE (Can't walk/can't walk straight). On an unknown date, the patient experienced HYPERTENSION (BP is high) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine was jammed by the pharmacist didn't administer gently.). At the time of the report, DIPLOPIA (Double vision), VISION BLURRED (Blurry vision/can't focus on her 3rd day), DIZZINESS (Dizziness) and FEELING ABNORMAL (She is feeling bad feel like something is on my eye/Patient mentioned that her eye is strange) had not resolved and HYPERTENSION (BP is high), GAIT DISTURBANCE (Can't walk/can't walk straight), BALANCE DISORDER (Having out of balance feeling/Her right eye doesn't coordinate .) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine was jammed by the pharmacist didn't administer gently.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   After 2 hrs of vaccination, patient experienced dizziness, blurry vision and can't walk. On Thursday, her one eye has double vision, and can't focus. On her 3rd day she was feeling bad, felt like something was on eye and had out of balance feeling. Patient felt that her eye was strange and can't walk straight. Her right eye doesn't coordinate. She thinks the problem was with her right eye. She went to internist and was referred to consult an eye specialist. According to the patient it was her 7th Moderna Covid-19 vaccine dose. Treatment information was not reported.  Company Comment This spontaneous case concerns a 86-years-old-female patient, with medical history of Diabetes, Heart failure and Thyroid disorder; concomitant products included INSULIN, SACUBITRIL, VALSARTAN and CARVEDILOL who experienced the seriousness criterion medically significant events of diplopia, vision blurred, dizziness, feeling abnormal; and the unexpected events of hypertension, gait disturbance, balance disorder and wrong technique in product usage process beginning the same day after 7th. dose of  mRNA-1273.815 vaccine. Treatment information was not reported. The medical history of is a contributor for hypertension, dizziness diplopia and vision blurred events. The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-741578 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741578:Husband case