Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blepharospasm, Excessive eye blinking, Impaired driving ability, Impaired work ability, Ophthalmoplegia
Clinical narrative: The patient had spasms where he cannot open his eyes; Patient cannot work, or drive; Patient cannot work, or drive; His eye muscles became weak; The blinking started in March 2022 with involuntary eye blinking/Constantly blinking; This spontaneous case was reported by a patient and describes the occurrence of OPHTHALMOPLEGIA (His eye muscles became weak) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A, 026B21A and 066H21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, the patient experienced EXCESSIVE EYE BLINKING (The blinking started in March 2022 with involuntary eye blinking/Constantly blinking). In March 2023, the patient experienced OPHTHALMOPLEGIA (His eye muscles became weak) (seriousness criterion medically significant). On an unknown date, the patient experienced BLEPHAROSPASM (The patient had spasms where he cannot open his eyes), IMPAIRED WORK ABILITY (Patient cannot work, or drive) and IMPAIRED DRIVING ABILITY (Patient cannot work, or drive). The patient was treated with BOTULINUM TOXIN TYPE A (BOTOX) in May 2023 at an unspecified dose and frequency. At the time of the report, OPHTHALMOPLEGIA (His eye muscles became weak), EXCESSIVE EYE BLINKING (The blinking started in March 2022 with involuntary eye blinking/Constantly blinking), BLEPHAROSPASM (The patient had spasms where he cannot open his eyes), IMPAIRED WORK ABILITY (Patient cannot work, or drive) and IMPAIRED DRIVING ABILITY (Patient cannot work, or drive) had not resolved.            Concomitant product use was not provided by the reporter.  It was not specified in which arm patient received the booster dose. Patient did experience any adverse events immediately after any of the three doses. However, blinking started in Mar-2022 with involuntary eye blinking. The patient noticed issues with his eyes in Mar-2023. The patient's eyes were constantly blinking, really started to blink and his eye muscles became weak, and the patient was not able to open his eyes voluntarily. The patient had spasms where he could not open his eyes. These side effects were still continuing. The patient cannot, work, or drive. The patient did see a Neurologist over Botox injections. Patient started botox injections at the recommendation of his Neurologist in late May- 2023.  Company comment: This is a spontaneous case concerning a 58-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) event of ophthalmoplegia among non-serious events. The events occurred after the firth dose of mRNA-1273 vaccine. The patient saw neurologist and treatment with Botox injections was prescribed. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the events were not recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.