Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram, Electrocardiogram, Generalised tonic-clonic seizure, Headache
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure) and SEIZURE (another seizure) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 047B21A and 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy. Concomitant products included LAMOTRIGINE for an unknown indication. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure) (seriousness criterion medically significant). On 12-Apr-2022, the patient experienced SEIZURE (another seizure) (seriousness criterion medically significant). On 01-Sep-2022, the patient experienced COVID-19 (tested positive for COVID). On an unknown date, the patient experienced HEADACHE (severe headache) and RASH (rash [after Topamax]). The patient was treated with LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for Headache, at a dose of 1000 milligram and TOPIRAMATE (TOPAMAX) for Headache, at an unspecified dose and frequency. At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure), SEIZURE (another seizure), COVID-19 (tested positive for COVID), HEADACHE (severe headache) and RASH (rash [after Topamax]) had resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2022, SARS-CoV-2 test: (Positive) tested positive for COVID. On an unknown date, Computerised tomogram: normal. On an unknown date, Electrocardiogram: normal. On an unknown date, Magnetic resonance imaging: normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure) to be related and RASH (rash [after Topamax]) to be not related. No further causality assessments were provided for SEIZURE (another seizure), COVID-19 (tested positive for COVID) and HEADACHE (severe headache). A week after patient had it, she had a grand mal seizure. She had never had any type of seizure, nothing, no epilepsy history in her family. The only thing we can attribute it to was to the booster. The patient stated she tested positive for COVID on 01-Sep-2022. She had the seizure on 01Feb2022. She was not put on any medication at the time because it was the first time and there was no history. Then she had another seizure on 12Apr2022. After which, her doctors prescribed her seizure medications. The patient reported severe headache that would wake her up after taking the Keppra. Then she took Topamax, but it made her break out into a rash. She had multiple tests - CAT scan, EKG, ECG, MRI - everything came back normal. She had follow-up visits with her doctors. She had life changes, like her driving has been restricted. No Other vaccines given within 1 month prior to Moderna COVID-19 vaccine. AE cause patient to seek medical care: emergency room on 01Feb2022. Company comment: This spontaneous case concerns a 54 years old female patient, with no medical history, who experienced unexpected serious (medically significant) AESI events of generalized tonic clonic seizure (reported as grand mal seizure) and seizure (reported as another seizure) and unexpected non serious AESI event of Covid-19. Event generalized tonic clonic seizure occurred 8 days and seizure occurred approximately 3 months and Covid-19 occurred 7 months 8 days after third dose of mRNA-1273 vaccine. Patient experienced grand mal seizure, patient had another seizure started on medications, patient reports severe headache that wake up after taking Keppra, patient took Topamax, but it made her break out into a rash. Patient had multiple tests CAT scan, EKG, ECG, MRI everything came back normal. Ongoing pandemic of Covid-19 remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 54 years old female patient, with no medical history, who experienced unexpected serious (medically significant) AESI events of generalized tonic clonic seizure (reported as grand mal seizure) and seizure (reported as another seizure) and unexpected non serious AESI event of Covid-19. Event generalized tonic clonic seizure occurred 8 days and seizure occurred approximately 3 months and Covid-19 occurred 7 months 8 days after third dose of mRNA-1273 vaccine. Patient experienced grand mal seizure, patient had another seizure started on medications, patient reports severe headache that wake up after taking Keppra, patient took Topamax, but it made her break out into a rash. Patient had multiple tests CAT scan, EKG, ECG, MRI everything came back normal. Ongoing pandemic of Covid-19 remains as a confounder. At the time of reporting events had resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.