Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye swelling, Headache, Impaired driving ability, Impaired work ability
Clinical narrative: had an injury due to the Moderna vaccine back in 2021; chronic migraines; swelling in the disc of eyes; blurred visions; unable to drive; unable to work; dizziness; headaches; This spontaneous case was reported by a patient and describes the occurrence of INJURY (had an injury due to the Moderna vaccine back in 2021) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INJURY (had an injury due to the Moderna vaccine back in 2021) (seriousness criterion hospitalization). On an unknown date, the patient experienced MIGRAINE (chronic migraines), EYE SWELLING (swelling in the disc of eyes), VISION BLURRED (blurred visions), IMPAIRED DRIVING ABILITY (unable to drive), IMPAIRED WORK ABILITY (unable to work), DIZZINESS (dizziness) and HEADACHE (headaches). At the time of the report, INJURY (had an injury due to the Moderna vaccine back in 2021), MIGRAINE (chronic migraines) and HEADACHE (headaches) outcome was unknown and EYE SWELLING (swelling in the disc of eyes), VISION BLURRED (blurred visions), IMPAIRED DRIVING ABILITY (unable to drive), IMPAIRED WORK ABILITY (unable to work) and DIZZINESS (dizziness) had resolved.            No concomitant medications was reported. It was reported that patient had put on an anti migraine medication and had adverse reaction of full body blisters to the medication and had to stop. For the events chronic migraines and headaches patient had to see a neurologist. Events swelling in the disc of eyes, dizziness, blurred visons, unable to drive and unable to work lasted for 6 weeks.  Company comment: This is a spontaneous case reported by a consumer, concerning a 27-year-old female patient, with no reported medical history, who experienced the unexpected and serious (due to hospitalization) event of injury, among other non-serious events which occurred on unknown day of vaccination with second dose of mRNA-1273. Patient complains of swelling in the disc of eyes, dizziness, blurred visons, unable to drive and unable to work lasted for 6 weeks. It was reported that patient was put on an anti-migraine medication and had adverse reaction of full body blisters related to medication which led to discontinuation of its intake.  No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event of injury was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as reported.; Sender's Comments: This is a spontaneous case reported by a consumer, concerning a 27-year-old female patient, with no reported medical history, who experienced the unexpected and serious (due to hospitalization) event of injury, among other non-serious events which occurred on unknown day of vaccination with second dose of mRNA-1273. Patient complains of swelling in the disc of eyes, dizziness, blurred visons, unable to drive and unable to work lasted for 6 weeks. It was reported that patient was put on an anti-migraine medication and had adverse reaction of full body blisters related to medication which led to discontinuation of its intake.  No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event of injury was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as reported.