Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Generalised tonic-clonic seizure, Heart rate
Clinical narrative: Had a severe  tonic-clonic seizure; This spontaneous case was reported by a pharmacist and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (Had a severe  tonic-clonic seizure) in a 28-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Patient had no allergies (medications, food and other products), was not ever had COVID plus test or diagnosis, no mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Depression. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 09-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 10-Apr-2022,  after starting mRNA-1273 (Spikevax), the patient experienced GENERALISED TONIC-CLONIC SEIZURE (Had a severe  tonic-clonic seizure) (seriousness criterion medically significant). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (Had a severe  tonic-clonic seizure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Heart rate: 125 (High) 125.     For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Patient got the second dose of the Moderna covid19 on the 9 Apr 2022 and 28 hours later had a sever tonic-clonic seizure. Patient was taking birth control pills. She had no similar event in pass.  The events "losing of the bladder" and "shaking violently, it lasted three minutes, and took 15 minutes to become aware again" are subsume under event PT: Generalized tonic-clonic seizure as both the events are sign and symptoms that can occur during the Clonic stage of seizure  She had a ER visit the following day.  Company Comment:  This spontaneous case concerns a 28-year-old female patient with concomitant use of Bupropion hydrochloride (Wellbutrin), who experienced the unexpected serious (medically significant) adverse event of special interest Generalised tonic-clonic seizure, that occurred 1 day after receiving the second dose of mRNA-1273 vaccine. Patient presented with loss of bladder control and violent shaking that lasted 3 minutes with awareness observed to have been regained after 15 minutes. Heart rate was high at 125 but electrocardiogram was reported as normal at the emergency room.  Patient had no history of seizures. Previously received first dose of COVID-19 vaccine was also by Moderna. The concomitant use of Bupropion hydrochloride (Wellbutrin) remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.  Event seriousness assessed per medical judgement.   This case was linked to MOD-2022-542549, MOD-2022-542528 (Patient Link).; Sender's Comments: This spontaneous case concerns a 28-year-old female patient with concomitant use of Bupropion hydrochloride (Wellbutrin), who experienced the unexpected serious (medically significant) adverse event of special interest Generalised tonic-clonic seizure, that occurred 1 day after receiving the second dose of mRNA-1273 vaccine. Patient presented with loss of bladder control and violent shaking that lasted 3 minutes with awareness observed to have been regained after 15 minutes. Heart rate was high at 125 but electrocardiogram was reported as normal at the emergency room.  Patient had no history of seizures. Previously received first dose of COVID-19 vaccine was also by Moderna. The concomitant use of Bupropion hydrochloride (Wellbutrin) remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.  Event seriousness assessed per medical judgement.