Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Seizure
Clinical narrative: another seizure; Seizure; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (another seizure) and SEIZURE (Seizure) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for Seizure.    The patient's past medical history included Stroke and Cardiac disorder (cardiac problems). Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe Rheumatoid arthritis).   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form and LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) (unknown route) 1 dosage form. In 2021, the patient experienced DIZZINESS (Dizzy). In November 2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant). In 2022, the patient experienced SEIZURE (another seizure) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 7 days due to SEIZURE. At the time of the report, SEIZURE (another seizure) and SEIZURE (Seizure) had resolved and DIZZINESS (Dizzy) outcome was unknown.         Concomitant medication was not provided by the reporter. The patient reported that in Nov 2021 patient had seizure and she was started on seizure medication. The patient was on keppra which made her dizzy and cut the medicine by half, since she was not having seizures. Patient wanted to get off because it made her dizzy.  Also reported that in 2022 patient had another seizure and patient was hospitalized  for one week and then rehab for week. She was not sure when she started having seizures and dizziness. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Company Comment: This spontaneous case concerns a 73-year-old, female patient with medical history of cerebrovascular accident who experienced the unexpected, serious (medically significant) adverse events of special interest of and unexpected, serious (hospitalization, medically significant) adverse event of special interest of Seizure after receiving the third dose of mRNA-1273 vaccine. Patient has completed the primary immunization series with mRNA-1273 eight months prior to the third dose with no reported information regarding adverse event. Patient developed the first episode of seizure on the same month of mRNA-1273 vaccination. Levetiracetam of unspecified dose was initiated but patient developed dizziness during treatment. The dose was decreased into half, but dizziness persisted. Few months after the initial episode of seizure, an attempt to withdraw the anticonvulsant was made. However, patient developed recurrence of seizure leading to hospital admission. She underwent physical rehabilitation and was discharged after a week. Medical history if cerebrovascular accident remains a confounder for seizure. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 73-year-old, female patient with medical history of cerebrovascular accident who experienced the unexpected, serious (medically significant) adverse events of special interest of and unexpected, serious (hospitalization, medically significant) adverse event of special interest of Seizure after receiving the third dose of mRNA-1273 vaccine. Patient has completed the primary immunization series with mRNA-1273 eight months prior to the third dose with no reported information regarding adverse event. Patient developed the first episode of seizure on the same month of mRNA-1273 vaccination. Levetiracetam of unspecified dose was initiated but patient developed dizziness during treatment. The dose was decreased into half, but dizziness persisted. Few months after the initial episode of seizure, an attempt to withdraw the anticonvulsant was made. However, patient developed recurrence of seizure leading to hospital admission. She underwent physical rehabilitation and was discharged after a week. Medical history if cerebrovascular accident remains a confounder for seizure. The benefit-risk relationship of mRNA-1273 is not affected by this report.