Age: 3.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Generalised tonic-clonic seizure, Motor dysfunction, Neurological symptom, Petit mal epilepsy
Clinical narrative: Severe Tonic-Clonic Seizure  after first dose; Absent seizures after first dose; Viral Rash after first dose; First Viral Rash after first dose; Severe Tonic-Clonic Seizure  after first dose; Cellulitis at injection site after first dose; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of GENERALISED TONIC-CLONIC SEIZURE (Severe Tonic-Clonic Seizure  after first dose), the second episode of GENERALISED TONIC-CLONIC SEIZURE (Severe Tonic-Clonic Seizure  after first dose) and PETIT MAL EPILEPSY (Absent seizures after first dose) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seizures. Concomitant products included LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for Seizures.    On 28-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2022, the patient experienced VACCINATION SITE CELLULITIS (Cellulitis at injection site after first dose). On 01-Jul-2022, the patient experienced the first episode of GENERALISED TONIC-CLONIC SEIZURE (Severe Tonic-Clonic Seizure  after first dose) (seriousness criterion medically significant) and VIRAL RASH (First Viral Rash after first dose). On 03-Jul-2022, the patient experienced PETIT MAL EPILEPSY (Absent seizures after first dose) (seriousness criterion medically significant) and VIRAL RASH (Viral Rash after first dose). On 05-Jul-2022, the patient experienced the second episode of GENERALISED TONIC-CLONIC SEIZURE (Severe Tonic-Clonic Seizure  after first dose) (seriousness criterion medically significant). The patient was treated with VALPROATE SEMISODIUM (DEPAKOTE) on 06-Jul-2022 for Seizures, at an unspecified dose and frequency and CEFALEXIN (KEFLEX [CEFALEXIN]) for Cellulitis, at an unspecified dose and frequency. At the time of the report, last episode of GENERALISED TONIC-CLONIC SEIZURE (Severe Tonic-Clonic Seizure  after last dose), PETIT MAL EPILEPSY (Absent seizures after first dose), VIRAL RASH (First Viral Rash after first dose), VIRAL RASH (Viral Rash after first dose) and VACCINATION SITE CELLULITIS (Cellulitis at injection site after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was on Keppra on and off since one year old. On an unknown date in Mar-2022, the treating physician restarted Keppra. Patient had absent seizures that lasted for few seconds. Patient started Depakote for one month in addition to Keppra.  company comment :  This spontaneous case concerns a female child aged 3 years with relevant medical history of Seizures reported, who experienced the unexpected serious (medically significant) AESI of one episode of Generalised tonic-clonic seizure, 2nd episode of Generalised tonic-clonic seizure and unexpected serious (medically significant) event of Petit mal epilepsy that occurred after first dose of mRNA-1273 vaccination. The event one episode of Generalised tonic-clonic seizure occurred after 3 days, 2nd episode of Generalised tonic-clonic seizure occurred after 7 days and Petit mal epilepsy occurred after 5 days of vaccination. Patient had severe Tonic-Clonic Seizure on 01JUL2022 lasting for 4 minutes, absent seizures on 03JUL2022 lasting a few seconds. On 05JUL2022, she had another Tonic-Clonic Seizure lasting for 1 minute and 30 seconds. She also had two episodes of non-serious events viral rashes. She had Cellulitis at injection site treated with antibiotic Keflex. Patient was treated with Depakote to continue for 1 month in addition to Keppra LIQUID. The baby takes 4.2ml  twice a day.  Outcome of the events was not known at the time of report. Relevant medical history could be confounder to the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a female child aged 3 years with relevant medical history of Seizures reported, who experienced the unexpected serious (medically significant) AESI of one episode of Generalised tonic-clonic seizure, 2nd episode of Generalised tonic-clonic seizure and unexpected serious (medically significant) event of Petit mal epilepsy that occurred after first dose of mRNA-1273 vaccination. The event one episode of Generalised tonic-clonic seizure occurred after 3 days, 2nd episode of Generalised tonic-clonic seizure occurred after 7 days and Petit mal epilepsy occurred after 5 days of vaccination. Patient had severe Tonic-Clonic Seizure on 01JUL2022 lasting for 4 minutes, absent seizures on 03JUL2022 lasting a few seconds. On 05JUL2022, she had another Tonic-Clonic Seizure lasting for 1 minute and 30 seconds. She also had two episodes of non-serious events viral rashes. She had Cellulitis at injection site treated with antibiotic Keflex. Patient was treated with Depakote to continue for 1 month in addition to Keppra LIQUID. The baby takes 4.2ml  twice a day.  Outcome of the events was not known at the time of report. Relevant medical history could be confounder to the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.