Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersomnia, Seizure, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (told the ushers that they were having a seizure/ knew they were having a seizure) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 013M20A, 012A21A and 939903) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Food allergy (Turmeric), Focal epilepsy, Blood pressure abnormal (blood pressure medication) and Depressive disorder (antidepressants Celexa). Concomitant products included CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) for Depression, LACOSAMIDE (VIMPAT) for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced VACCINATION SITE PAIN (haves a sore arm around the injection site and is not so bad). On 23-Apr-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SEIZURE (told the ushers that they were having a seizure/ knew they were having a seizure) (seriousness criterion medically significant). On 24-Apr-2022, the patient experienced HYPERSOMNIA (slept all day). At the time of the report, SEIZURE (told the ushers that they were having a seizure/ knew they were having a seizure) was resolving and HYPERSOMNIA (slept all day) and VACCINATION SITE PAIN (haves a sore arm around the injection site and is not so bad) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications included unspecified seizure medication and blood pressure medication. It was reported that, 24 hours after getting the second booster the patient got diarrhea but was not sure, had to use the toilet a few times, and on the theater had to go up some stairs, and felt dizzy, and was not firm on the steps, and told the ushers that patient had a seizure. Also was very dizzy going up the stairs. Patient knew she had a seizure, but did not remember off been in the ambulance, going to the hospital, been put in IV, or been admit in the hospital for a couple hours. It was stated that she had no reactions to any of the other doses, but now had a sore arm around the injection site and was not so bad, and that after the first booster she also got a big seizure and there companion could not understand what she was saying and she was extraordinary dizzy until that day, and that they slept all day. The patient never had COVID positive test or diagnosis. The patient did not receive any other vaccines within 1 month prior to Moderna COVID-19 vaccine. Adverse event cause patient to seek medical care. Patient experienced a similar event in the past. Patient's symptoms were improved. No treatment medication was reported. Company comment: This spontaneous case concerns an 77-year-old female patient with underlying medical history Focal epilepsy, blood pressure abnormal and depressive disorder who experienced the unexpected, serious (medically significant) AESI of Seizure and unexpected, non-serious AESI of  hypersomnia. The event Seizure occurred 1 day after receiving a dose of mRNA1273 and Hypersomnia started 2 days after administration of mRNA1273 as fourth dose of COVID-19 vaccine. The events may be in association with each other. The patient had seizure and was having trouble remembering the events that happened thereafter, persistence of dizziness was also noted. The clinical course and treatment details were not stated in the case. The patient's advanced age and underlying medical history of Focal epilepsy, blood pressure abnormal and depressive disorder may be considered as risk factors to the event Seizure and Hypersomnia and remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2022-548571 (Patient Link). Sender's Comments: This spontaneous case concerns an 77-year-old female patient with underlying medical history Focal epilepsy, blood pressure abnormal and depressive disorder who experienced the unexpected, serious (medically significant) AESI of Seizure and unexpected, non-serious AESI of  hypersomnia. The event Seizure occurred 1 day after receiving a dose of mRNA1273 and Hypersomnia started 2 days after administration of mRNA1273 as fourth dose of COVID-19 vaccine. The events may be in association with each other. The patient had seizure and was having trouble remembering the events that happened thereafter, persistence of dizziness was also noted. The clinical course and treatment details were not stated in the case. The patient's advanced age and underlying medical history of Focal epilepsy, blood pressure abnormal and depressive disorder may be considered as risk factors to the event Seizure and Hypersomnia and remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report.