Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Autoimmune disorder, Cerebrovascular accident, Computerised tomogram, Dysarthria
Clinical narrative: inflammation of optic nerve/ optic neuritis; Aphasia/Stroke like aphasia; Numbness in my right arm; Slurred speech; maybe a stroke; numbness in face; Autoimmune disease called MOG; blurred vision; losing vision in left eye; Swelling on my retina; Seizure; Status migrainosus/persistent migraine; Numbness in my right arm,; Slurred speech; This spontaneous case was reported by a consumer and describes the occurrence of APHASIA (Aphasia/Stroke like aphasia), HYPOAESTHESIA (Numbness in my right arm), the second episode of DYSARTHRIA (Slurred speech), CEREBROVASCULAR ACCIDENT (maybe a stroke), OPTIC NEURITIS (inflammation of optic nerve/ optic neuritis), SEIZURE (Seizure), STATUS MIGRAINOSUS (Status migrainosus/persistent migraine), RETINAL OEDEMA (Swelling on my retina) and AUTOIMMUNE DISORDER (Autoimmune disease called MOG) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Epilepsy (Epilepsy stable since age 7.) since 1995. Concomitant products included LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) from 2015 to an unknown date for Seizures.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2021, the patient experienced STATUS MIGRAINOSUS (Status migrainosus/persistent migraine) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness in my right arm,) and the first episode of DYSARTHRIA (Slurred speech). On 24-Aug-2021, the patient experienced APHASIA (Aphasia/Stroke like aphasia) (seriousness criteria hospitalization and medically significant), HYPOAESTHESIA (Numbness in my right arm) (seriousness criterion hospitalization), the second episode of DYSARTHRIA (Slurred speech) (seriousness criteria hospitalization and medically significant) and CEREBROVASCULAR ACCIDENT (maybe a stroke) (seriousness criteria hospitalization and medically significant). On 27-Aug-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant). On 01-Sep-2021, the patient experienced RETINAL OEDEMA (Swelling on my retina) (seriousness criterion medically significant), VISION BLURRED (blurred vision ) and VISUAL IMPAIRMENT (losing vision in left eye). On 05-Oct-2021, the patient experienced OPTIC NEURITIS (inflammation of optic nerve/ optic neuritis) (seriousness criteria hospitalization and medically significant). In October 2021, the patient experienced AUTOIMMUNE DISORDER (Autoimmune disease called MOG) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPOAESTHESIA (numbness in face). The patient was hospitalized from 24-Aug-2021 to 26-Aug-2021 due to APHASIA, CEREBROVASCULAR ACCIDENT, DYSARTHRIA and HYPOAESTHESIA. The patient was treated with TOTAL PARENTERAL NUTRITION INJECTION (25) in August 2021 at an unspecified dose and frequency and KETOROLAC TROMETHAMINE (TORADOL) (intravenous) in August 2021 at a dose of IV Toradol. On 27-Aug-2021, SEIZURE (Seizure) had resolved. On 10-Sep-2021, APHASIA (Aphasia/Stroke like aphasia) had resolved with sequelae. At the time of the report, HYPOAESTHESIA (Numbness in my right arm), the last episode of DYSARTHRIA (Slurred speech), CEREBROVASCULAR ACCIDENT (maybe a stroke), OPTIC NEURITIS (inflammation of optic nerve/ optic neuritis), RETINAL OEDEMA (Swelling on my retina), AUTOIMMUNE DISORDER (Autoimmune disease called MOG), VISION BLURRED (blurred vision ), HYPOAESTHESIA (Numbness in my right arm,), VISUAL IMPAIRMENT (losing vision in left eye) and HYPOAESTHESIA (numbness in face) outcome was unknown and STATUS MIGRAINOSUS (Status migrainosus/persistent migraine) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2021, Computerised tomogram: normal (normal) Normal. On 04-Aug-2021, Magnetic resonance imaging: normal (normal) Normal. On 24-Aug-2021, Computerised tomogram: normal (normal) Normal. On 24-Aug-2021, Magnetic resonance imaging: normal (normal) Normal. On 05-Oct-2021, Magnetic resonance imaging head: abnormal (abnormal) discovered 22mm of inflammation of my optic nerve.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered APHASIA (Aphasia/Stroke like aphasia), SEIZURE (Seizure) and STATUS MIGRAINOSUS (Status migrainosus/persistent migraine) to be possibly related. No further causality assessments were provided for HYPOAESTHESIA (Numbness in my right arm), DYSARTHRIA (Slurred speech), CEREBROVASCULAR ACCIDENT (maybe a stroke), OPTIC NEURITIS (inflammation of optic nerve/ optic neuritis), RETINAL OEDEMA (Swelling on my retina), AUTOIMMUNE DISORDER (Autoimmune disease called MOG), VISION BLURRED (blurred vision ), HYPOAESTHESIA (Numbness in my right arm,), DYSARTHRIA (Slurred speech), VISUAL IMPAIRMENT (losing vision in left eye) and HYPOAESTHESIA (numbness in face).    The patient started having Seizures recently and dosage for Epilepsy medicine increased to 1500 mg from 1000 mg.  In Aug-2021, the patient had multiple visits to ER, 6 months after final vaccination.  The patient had no symptoms immediately after vaccination, but she started noticing the change in her body (being able to grasp, numbness in face) later.  On 04-Aug-2021, the patient was treated with IV Toradol.  On 24-Aug-2021, the patient was treated with treated TPN.  On 27-Aug-2021, the patient had Seizure and taken to Urgent care where they gave her IV fluids. After that incident, the patient noticed loss of vision in her left eye.   On 01-Sep-2021, the patient consulted Ophthalmologist as she began losing vision in her left eye and had blurred vision. He found swelling on her retina. Ophthalmologist identified swelling of her optic nerve.   On 05-Oct-2021, the patient saw the neuro ophthalmologist ran a field test and optic nerve tests. The patient underwent a lumbar puncture test, results were not provided.  On 05-Oct-2021, the patient was hospitalized for 7 days. The patient received plasmapheresis and IV steroids treatment.   Upon discharge, the patient received diagnosis of optic neuritis and autoimmune disease of MOG.  The patient stated that all things were triggered by immune response and now, she would have to be monitored for flare.  This case concerns a 32 year-old female patient with history of epilepsy, who experienced the unexpected serious events of Seizure, Status migrainosus, Retinal oedema, Optic neuritis, Autoimmune disorder, and Cerebrovascular accident. The event s occurred approximately 6-9 months after the second dose of mRNA-1273 vaccine. Details of the events, diagnostic criteria, and clinical course were not provided.The patient's history of epilepsy likely contributed to the event of Seizure. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-363446 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Significant Follow up-Concomitant medication and treatment medications updated. Secondary Reporters details updated. Patient information and relevant history updated, Vaccine facility information updated, Event-Status migrainosus outcome updated. Event-Aphasia hospitalization dates and outcome updated. Event-seizure stop date and outcome updated.; Sender's Comments: This case concerns a 32 year-old female patient with history of epilepsy, who experienced the unexpected serious events of Seizure, Status migrainosus, Retinal oedema, Optic neuritis, Autoimmune disorder, and Cerebrovascular accident. The event s occurred approximately 6-9 months after the second dose of mRNA-1273 vaccine. Details of the events, diagnostic criteria, and clinical course were not provided.The patient's history of epilepsy likely contributed to the event of Seizure. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.