Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram, Epilepsy
Clinical narrative: Epilepsy; This spontaneous case was reported by a patient and describes the occurrence of EPILEPSY (Epilepsy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 027B21A and 027B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Asthma, Allergy to antibiotic (Keflex), Allergy to antibiotic (Bactrim) and Allergy to antibiotic (Ciprofloxacin).   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EPILEPSY (Epilepsy) (seriousness criterion medically significant). At the time of the report, EPILEPSY (Epilepsy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electroencephalogram: Epilepsy was confirmed through EEG..         No relevant concomitant medications were reported. Patient reported that she felt normal after getting primary vaccine series, however hours after getting the first booster shot she started to experiencing seizures. 14 seizures were reported. Patient stated that she did not have epilepsy previously. Patient reports of having pregnancy plan by Jan of 2023.  It was reported that this situation has severely impacted her life. No treatment medication reported.  Company comment: This is a spontaneous case concerning a 31-year-old, female patient with no relevant medical history. Patient has vaccination history of receiving first and second dose of mRNA-1273. Patient experienced the unexpected serious (medically significant) AESI event of epilepsy. The event occurred hours after the first booster dose of mRNA-1273 vaccine administration. It was reported that the patient experienced 14 seizures. Epilepsy was confirmed through electroencephalogram (EEG). It was reported that the patient has no history of epilepsy. At the time of report, patient has schedule for follow up with health care personnel (HCP). No other information surrounding the event was reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 31-year-old, female patient with no relevant medical history. Patient has vaccination history of receiving first and second dose of mRNA-1273. Patient experienced the unexpected serious (medically significant) AESI event of epilepsy. The event occurred hours after the first booster dose of mRNA-1273 vaccine administration. It was reported that the patient experienced 14 seizures. Epilepsy was confirmed through electroencephalogram (EEG). It was reported that the patient has no history of epilepsy. At the time of report, patient has schedule for follow up with health care personnel (HCP). No other information surrounding the event was reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.