Reporte zur Charge 030M20A,NDC8077

Symptomtext

Atrial Fibrillation; Seizure; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial Fibrillation) and SEIZURE (Seizure) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A,NDC80777-273-10) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Atrial fibrillation (Patient gets Atrial fibrillation periodically.). On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Atrial Fibrillation) (seriousness criterion medically significant), SEIZURE (Seizure) (seriousness criterion medically significant) and NAUSEA (Nauseous). In February 2021, SEIZURE (Seizure) had resolved. At the time of the report, ATRIAL FIBRILLATION (Atrial Fibrillation) and NAUSEA (Nauseous) outcome was unknown. No concomitant product was provided. No treatment information was provided. Patient does not have a seizure before. They called 911 but seizure was over-with shortly before they arrived. Company comment: This Spontaneous case concerns a 78-year-old, male patient, with medical history of atrial fibrillation, who experienced the unexpected, serious (Medically significant) and AESI of atrial fibrillation and seizure, among others. The patient developed atrial fibrillation and seizure after 1 day of receiving the second dose of mRNA-1273 vaccine. It was reported that the patient had episodes of atrial fibrillation before, however, it was the first time he experienced a seizure. Patient's age and the with medical history of atrial fibrillation remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events atrial fibrillation and seizure were automatically upgraded as a Serious event as per IME list and kept as serious as per medical judgement, despite they were reported as non-serious.; Sender's Comments: This Spontaneous case concerns a 78-year-old, male patient, with medical history of atrial fibrillation, who experienced the unexpected, serious (Medically significant) and AESI of atrial fibrillation and seizure, among others. The patient developed atrial fibrillation and seizure after 1 day of receiving the second dose of mRNA-1273 vaccine. It was reported that the patient had episodes of atrial fibrillation before, however, it was the first time he experienced a seizure. Patient's age and the with medical history of atrial fibrillation remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events atrial fibrillation and seizure were automatically upgraded as a Serious event as per IME list and kept as serious as per medical judgement, despite they were reported as non-serious.