Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Dizziness to the point that she can't drive, When she talks, it exacerbates the dizziness; Vertigo; Tachycardia; Low blood pressure; Tingling face, Tingling arm, Tingling feet, Tingling back; Tingling mouth; Insomnia; Bruised feeling at the bottom of her heels, Bruised feeling at the bottom of her feet; Trouble grasping left arm (opening and closing); Bulging veins in her arms, Bulging veins in her legs; Headache; Right leg delay; Tinnitus in both ears; Fullness in the right ear.; she can't drive her daughter to school or sporting activities; Severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness to the point that she can't drive, When she talks, it exacerbates the dizziness), VERTIGO (Vertigo), TACHYCARDIA (Tachycardia), HYPOTENSION (Low blood pressure), PARAESTHESIA (Tingling face, Tingling arm, Tingling feet, Tingling back), PARAESTHESIA ORAL (Tingling mouth), INSOMNIA (Insomnia), CONTUSION (Bruised feeling at the bottom of her heels, Bruised feeling at the bottom of her feet), MOTOR DYSFUNCTION (Trouble grasping left arm (opening and closing)), VEIN DISORDER (Bulging veins in her arms, Bulging veins in her legs), HEADACHE (Headache), GAIT DISTURBANCE (Right leg delay), TINNITUS (Tinnitus in both ears), EAR DISCOMFORT (Fullness in the right ear.), DIARRHOEA (Severe diarrhea) and IMPAIRED DRIVING ABILITY (she can't drive her daughter to school or sporting activities) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 016B21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (Severe diarrhea) (seriousness criterion hospitalization). On an unknown date, the patient experienced DIZZINESS (Dizziness to the point that she can't drive, When she talks, it exacerbates the dizziness) (seriousness criterion hospitalization), VERTIGO (Vertigo) (seriousness criterion hospitalization), TACHYCARDIA (Tachycardia) (seriousness criterion hospitalization), HYPOTENSION (Low blood pressure) (seriousness criterion hospitalization), PARAESTHESIA (Tingling face, Tingling arm, Tingling feet, Tingling back) (seriousness criterion hospitalization), PARAESTHESIA ORAL (Tingling mouth) (seriousness criterion hospitalization), INSOMNIA (Insomnia) (seriousness criterion hospitalization), CONTUSION (Bruised feeling at the bottom of her heels, Bruised feeling at the bottom of her feet) (seriousness criterion hospitalization), MOTOR DYSFUNCTION (Trouble grasping left arm (opening and closing)) (seriousness criterion hospitalization), VEIN DISORDER (Bulging veins in her arms, Bulging veins in her legs) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization), GAIT DISTURBANCE (Right leg delay) (seriousness criterion hospitalization), TINNITUS (Tinnitus in both ears) (seriousness criterion hospitalization), EAR DISCOMFORT (Fullness in the right ear.) (seriousness criterion hospitalization) and IMPAIRED DRIVING ABILITY (she can't drive her daughter to school or sporting activities) (seriousness criterion hospitalization). On 18-Dec-2021, DIARRHOEA (Severe diarrhea) had resolved. At the time of the report, DIZZINESS (Dizziness to the point that she can't drive, When she talks, it exacerbates the dizziness), VERTIGO (Vertigo), TACHYCARDIA (Tachycardia), HYPOTENSION (Low blood pressure), PARAESTHESIA (Tingling face, Tingling arm, Tingling feet, Tingling back), PARAESTHESIA ORAL (Tingling mouth), INSOMNIA (Insomnia), CONTUSION (Bruised feeling at the bottom of her heels, Bruised feeling at the bottom of her feet), MOTOR DYSFUNCTION (Trouble grasping left arm (opening and closing)), VEIN DISORDER (Bulging veins in her arms, Bulging veins in her legs), HEADACHE (Headache), GAIT DISTURBANCE (Right leg delay), TINNITUS (Tinnitus in both ears), EAR DISCOMFORT (Fullness in the right ear.) and IMPAIRED DRIVING ABILITY (she can't drive her daughter to school or sporting activities) had not resolved.            Patient stated that she was having side effects with the Moderna COVID 19 vaccine booster dose. Immediately after getting the booster dose she had severe diarrhea for 12 days. Other side effects with the booster includes dizziness, vertigo, tachycardia, low blood pressure, tingling - face, mouth, arm, feet and back, insomnia, bruised feeling at the bottom of her feet and heels, trouble grasping left arm (opening and closing), bulging veins in her arms and legs, headache, right leg delay, tinnitus in both ears, and fullness in the right ear. When she talks, it exacerbates the dizziness. She had dizziness to the point that she cannot drive her car. she cannot drive her daughter to school or sporting activities. She was still having the side effects and has been to the emergency 3 times and have spent the night in the hospital. All her doctors agreed that all these side effects are related to her getting the Moderna COVID 19 vaccine. She was still having the side effects.   Company comment: This regulatory authority case concerns a 49-year-old female patient with no medical history reported, who experienced serious unexpected events of impaired driving ability, dizziness, vertigo, tachycardia, hypotension, paresthesia, paraesthesia oral, insomnia, contusion, motor dysfunction, vein disorder, headache, gait disturbance, tinnitus, ear discomfort and diarrhoea, that occurred after the booster dose of the mRNA-1273. Time to onset for the event of diarrhoea was immediately after the booster whereas the exact onset latency for the remining events was not provided. The patient reported having one hospitalization and multiple emergency room visits however, it was not specified which events led to them. The rechallenge was not applicable due to occurrence after the booster dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This regulatory authority case concerns a 49-year-old female patient with no medical history reported, who experienced serious unexpected events of impaired driving ability, dizziness, vertigo, tachycardia, hypotension, paresthesia, paraesthesia oral, insomnia, contusion, motor dysfunction, vein disorder, headache, gait disturbance, tinnitus, ear discomfort and diarrhoea, that occurred after the booster dose of the mRNA-1273. Time to onset for the event of diarrhoea was immediately after the booster whereas the exact onset latency for the remining events was not provided. The patient reported having one hospitalization and multiple emergency room visits however, it was not specified which events led to them. The rechallenge was not applicable due to occurrence after the booster dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.