Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Generalised tonic-clonic seizure, Magnetic resonance imaging, Muscle twitching, Seizure
Clinical narrative: many mini seizures/had an EEG on 23Sep2021 that came back abnormal & she was told the left side of the brain is prone to seizures/About once a day or so her eyes will go back & forth (left-right left-right) & she has the feeling of sitting up too fas; has twitches in her right leg daily all day long with only minutes in between the twitches; About once a day more often in the evenings her right leg will start kicking; Sometimes when stepping forward with her right leg she almost falls all the way forward; eyes will go back & forth; About once a day or so her eyes will go back & forth (left-right left-right) & she has the feeling of sitting up too fast that lasts about 30 seconds; tonic-clonic seizure in her sleep; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizure in her sleep) and SEIZURE (many mini seizures/had an EEG on 23Sep2021 that came back abnormal & she was told the left side of the brain is prone to seizures/About once a day or so her eyes will go back & forth (left-right left-right) & she has the feeling of sitting up too fas) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizure in her sleep) (seriousness criterion medically significant). On an unknown date, the patient experienced SEIZURE (many mini seizures/had an EEG on 23Sep2021 that came back abnormal & she was told the left side of the brain is prone to seizures/About once a day or so her eyes will go back & forth (left-right left-right) & she has the feeling of sitting up too fas) (seriousness criterion medically significant), MUSCLE TWITCHING (has twitches in her right leg daily all day long with only minutes in between the twitches), DYSKINESIA (About once a day more often in the evenings her right leg will start kicking), GAIT DISTURBANCE (Sometimes when stepping forward with her right leg she almost falls all the way forward), EYE MOVEMENT DISORDER (eyes will go back & forth) and EYE MOVEMENT DISORDER (About once a day or so her eyes will go back & forth (left-right left-right) & she has the feeling of sitting up too fast that lasts about 30 seconds ). The patient was treated with LAMOTRIGINE for Seizures, at an unspecified dose and frequency. At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizure in her sleep), SEIZURE (many mini seizures/had an EEG on 23Sep2021 that came back abnormal & she was told the left side of the brain is prone to seizures/About once a day or so her eyes will go back & forth (left-right left-right) & she has the feeling of sitting up too fas), MUSCLE TWITCHING (has twitches in her right leg daily all day long with only minutes in between the twitches), DYSKINESIA (About once a day more often in the evenings her right leg will start kicking), GAIT DISTURBANCE (Sometimes when stepping forward with her right leg she almost falls all the way forward), EYE MOVEMENT DISORDER (eyes will go back & forth) and EYE MOVEMENT DISORDER (About once a day or so her eyes will go back & forth (left-right left-right) & she has the feeling of sitting up too fast that lasts about 30 seconds ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) normal. In 2021, Computerised tomogram: normal (normal) normal. In 2021, Magnetic resonance imaging: normal (normal) normal. On 23-Sep-2021, Electrocardiogram: abnormal (abnormal) left side of the brain was prone to seizures..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Patient reported that had no triggers for the seizures. No history of anything like this, and no family history of epilepsy. Patient stated that did not had drugs and barely drinks.  This case concerns a 61-year-old male patient with no reported medical history who experienced the unexpected events of generalized tonic clonic seizure, and seizure. The events occurred 11 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as events occurred after the second dose. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) in not affected by this report.  The events are medical important events and adverse events of special interest; Sender's Comments: This case concerns a 61-year-old male patient with no reported medical history who experienced the unexpected events of generalized tonic clonic seizure, and seizure. The events occurred 11 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as events occurred after the second dose. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) in not affected by this report.  The events are medical important events and adverse events of special interest