Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Diarrhoea, Disturbance in attention, Dysarthria, Eye swelling
Clinical narrative: Slurring her speech; "I could not open my eyes and look at a screen"; Periorbital edema; Could not think clearly; Thought she was having a stroke; Could not focus on a computer screen, tv, phone, or read; Headache/Whole entire head hurt; Vomiting; Diarrhea; Miserable; Eyes were swollen all around her eyes; Migraine/ chain of migraines/ migraine pain; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of MENTAL IMPAIRMENT (Could not think clearly) and CEREBROVASCULAR ACCIDENT (Thought she was having a stroke) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine (History of migraines). Concomitant products included ELETRIPTAN HYDROBROMIDE (RELPAX) and NAPROXEN SODIUM (ALEVE) for Migraine.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced MIGRAINE (Migraine/ chain of migraines/ migraine pain). On 07-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), FEELING ABNORMAL (Miserable) and VOMITING (Vomiting). In January 2021, the patient experienced EYE SWELLING (Eyes were swollen all around her eyes). On an unknown date, the patient experienced MENTAL IMPAIRMENT (Could not think clearly) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (Thought she was having a stroke) (seriousness criterion intervention required), DYSARTHRIA (Slurring her speech), PHOTOPHOBIA ("I could not open my eyes and look at a screen"), PERIORBITAL OEDEMA (Periorbital edema), DISTURBANCE IN ATTENTION (Could not focus on a computer screen, tv, phone, or read) and HEADACHE (Headache/Whole entire head hurt). At the time of the report, MENTAL IMPAIRMENT (Could not think clearly), CEREBROVASCULAR ACCIDENT (Thought she was having a stroke), MIGRAINE (Migraine/ chain of migraines/ migraine pain), DYSARTHRIA (Slurring her speech), PHOTOPHOBIA ("I could not open my eyes and look at a screen"), PERIORBITAL OEDEMA (Periorbital edema), DIARRHOEA (Diarrhea), FEELING ABNORMAL (Miserable), EYE SWELLING (Eyes were swollen all around her eyes), DISTURBANCE IN ATTENTION (Could not focus on a computer screen, tv, phone, or read), VOMITING (Vomiting) and HEADACHE (Headache/Whole entire head hurt) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Magnetic resonance imaging: indicates bright spot which could be migraine (abnormal) Bright spot which could be migraine. In January 2021, SARS-CoV-2 test: Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information mentioned while in ER had infusions of pain medications and ketorolac, steroids, and antihistamines. Would also ice head for pain relief.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Additional events, Medical history, event outcome and action taken updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded, noting the medical history of migraines in the patient as a confounder.