Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Generalised tonic-clonic seizure, Loss of consciousness, Seizure
Clinical narrative: grand mal seizures; blacks out momentarily; difficulty of breathing; teeth clenching; eyes shifting to the right side; movement in chest; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures), LOSS OF CONSCIOUSNESS (blacks out momentarily), DYSPNOEA (difficulty of breathing), SEIZURE (teeth clenching) and SEIZURE (eyes shifting to the right side) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Myelodysplastic syndrome in November 2020 and Brain stem hematoma (A brain surgery in feb2021 where a left cranial flap was done for another brain hematoma.) in February 2021. Concomitant products included AZACITIDINE (VIDAZA) for White blood cell count abnormal.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (blacks out momentarily) (seriousness criterion medically significant), DYSPNOEA (difficulty of breathing) (seriousness criterion medically significant), SEIZURE (teeth clenching) (seriousness criterion medically significant), SEIZURE (eyes shifting to the right side) (seriousness criterion medically significant) and CHEST DISCOMFORT (movement in chest). The patient was hospitalized from 01-May-2021 to 06-May-2021 due to GENERALISED TONIC-CLONIC SEIZURE. The patient was treated with LACOSAMIDE at a dose of 200 mg twice a day and LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) ongoing since an unknown date at a dose of 1500 mg twice a day. On 03-May-2021, GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (blacks out momentarily), DYSPNOEA (difficulty of breathing), SEIZURE (teeth clenching), SEIZURE (eyes shifting to the right side) and CHEST DISCOMFORT (movement in chest) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had same experience on 26Apr2021 (6:00am) and 30 apr20219(5:30pm), his had a grand mal seizure. Emergency medical technician (EMT) was called and he was brought to the hospital and was released after a few hours.Patient had also experience on 01 May 2021, he had 3 episodes of grand mal seizures while still at the ER. Because there was no room available, he was transferred to another hospital. Also same experience on 2 and 3 may 2021.He has a ready donor for a transplant at a medical center but since he has is still having the seizures the doctors will not do it; surgery on 02Jan2021 for a subdural hematoma (not brain surgery but they had to access the bleed through his groin.  Company comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.