Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: after the first booster they also got a big seizure companion could not understand what she was saying; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (after the first booster they also got a big seizure companion could not understand what she was saying) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy, Blood pressure, Focal epilepsy and Depression. Concomitant products included CITALOPRAM (CELEXA) for Depression, LACOSAMIDE (VIMPAT) for Seizure.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced SEIZURE (after the first booster they also got a big seizure companion could not understand what she was saying) (seriousness criterion medically significant). At the time of the report, SEIZURE (after the first booster they also got a big seizure companion could not understand what she was saying) 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. Patient dosage text reported as First booster dose. 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. The patients symptoms were improved. It was stated that the patient 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 the patient also got a big seizure, and her companion could not understand what she was saying and that the patient was extraordinary dizzy until this day.  Company comment: This is a spontaneous case concerning a 77-year-old, female patient with no reported medical history and with relevant concomitant medications of Lacosamide (Vimpat) and Citalopram (Celexa) and vaccine history of receiving first and second dose of mRNA-1273 vaccine, who experienced the unexpected serious (medically significant) AESI event of seizure. The event occurred the same day after the first booster dose of mRNA-1273 vaccine administration. The relevant concomitant medications of Lacosamide (Vimpat) and Citalopram (Celexa) remain confounders for the event seizure. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-548597 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 77-year-old, female patient with no reported medical history and with relevant concomitant medications of Lacosamide (Vimpat) and Citalopram (Celexa) and vaccine history of receiving first and second dose of mRNA-1273 vaccine, who experienced the unexpected serious (medically significant) AESI event of  seizure. The event occurred the same day after the first booster dose of mRNA-1273 vaccine administration. The relevant concomitant medications of Lacosamide (Vimpat) and Citalopram (Celexa) remain confounders for the event seizure. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.