Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Juvenile myoclonic epilepsy, Seizure, Syncope, Vision blurred
Clinical narrative: seizures/seizures, kind of black outs; kind of black outs but only with my vision blurred; Was diagnosed with JME epilepsy; Syncope / cough syncope; This spontaneous case was reported by a patient and describes the occurrence of SEIZURE (seizures/seizures, kind of black outs), VISION BLURRED (kind of black outs but only with my vision blurred) and JUVENILE MYOCLONIC EPILEPSY (Was diagnosed with JME epilepsy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer and Epilepsy (The patient said that previously, when little, was diagnosed with epilepsy but afterwards it went away. ). Concurrent medical conditions included Lung disease. Concomitant products included ZONISAMIDE and LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SEIZURE (seizures/seizures, kind of black outs) (seriousness criteria hospitalization and medically significant), VISION BLURRED (kind of black outs but only with my vision blurred) (seriousness criteria hospitalization and medically significant), JUVENILE MYOCLONIC EPILEPSY (Was diagnosed with JME epilepsy) (seriousness criterion medically significant) and SYNCOPE (Syncope / cough syncope). The patient was hospitalized on 13-May-2021 due to SEIZURE and VISION BLURRED. At the time of the report, SEIZURE (seizures/seizures, kind of black outs), VISION BLURRED (kind of black outs but only with my vision blurred), JUVENILE MYOCLONIC EPILEPSY (Was diagnosed with JME epilepsy) and SYNCOPE (Syncope / cough syncope) outcome was unknown.            Patient was feeling like her brain was not getting oxygen The patient is currently having medication and reports to be non functional due to the medications.  Treatment information was not provided.  Very limited info provided and further FU is required to clarify the SAEs and has been requested. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The evaluation of causality is confounded by the past history of epilepsy.   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow-up received included significant data: Medical history, Dose details, Concomitant medication are updated. New events and hospitalization details are added. Reporter details and patient details updated.; Sender's Comments: Very limited info provided and further FU is required to clarify the SAEs and has been requested. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The evaluation of causality is confounded by the past history of epilepsy.