Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dyskinesia, Pyrexia, Seizure
Clinical narrative: felt like he was having a seizure; arms were failing,were going in all directions; fever of 102.3 degrees; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (felt like he was having a seizure) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced SEIZURE (felt like he was having a seizure) (seriousness criterion medically significant), DYSKINESIA (arms were failing,were going in all directions) and PYREXIA (fever of 102.3 degrees). The patient was treated with TEMAZEPAM for Adverse event, at an unspecified dose and frequency. On 14-Apr-2021, SEIZURE (felt like he was having a seizure), DYSKINESIA (arms were failing,were going in all directions) and PYREXIA (fever of 102.3 degrees) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Body temperature: 102.3 (High) 102.3 degrees.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provide  Consumer mentioned he thought he was having a stroke because he has had one. The Patient went to the hospital but was not hospitalized for prolonged period or overnight.  Company comment: This case concerns a 69-year-old, male patient with a history of stroke, who experienced the unexpected serious AESI event of seizure, with concurrent non-serious events of movement abnormal and pyrexia. The events occurred approximately on the same day after the second dose of mRNA-1273 vaccine. The patient was treated with TEMAZEPAM. The rechallenge was not applicable since the events happened after the second dose and no information on additional dosing is available. The medical history of stroke and concurrent event pyrexia remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.; Sender's Comments: This case concerns a 69-year-old, male patient with a history of stroke, who experienced the unexpected serious AESI event of seizure, with concurrent non-serious events of movement abnormal and pyrexia. The events occurred approximately on the same day after the second dose of mRNA-1273 vaccine. The patient was treated with TEMAZEPAM. The rechallenge was not applicable since the events happened after the second dose and no information on additional dosing is available. The medical history of stroke and concurrent event pyrexia remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.