Reporte zur Charge 9LU-18343-69467

Symptomtext

Heart issue; Severe chest pain; Inappropriate route of vaccination; Heart fluttering; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart fluttering) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 9LU-18343-69467) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arrhythmia, Hypertension and Asthma. On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) .5 milliliter. On 29-Apr-2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant). On 30-Apr-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). On an unknown date, the patient experienced CARDIAC DISORDER (Heart issue) and CHEST PAIN (Severe chest pain). The patient was treated with LORAZEPAM for Adverse event, at an unspecified dose and frequency. On 30-Apr-2021, CARDIAC FLUTTER (Heart fluttering) was resolving, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. At the time of the report, CARDIAC DISORDER (Heart issue) and CHEST PAIN (Severe chest pain) outcome was unknown. Not Provided mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosing remained unchanged. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment - Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the serious unexpected event of Cardiac flutter and non-serious events of Cardiac disorder and Chest pain, a causal relationship cannot be excluded; however case causality is confounded by the patient's known history of arrhythmia and hypertension. Causality for the event Incorrect route of product administration assessed as not applicable. Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow up received included new event added.; Sender's Comments: Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the serious unexpected event of Cardiac flutter and non-serious events of Cardiac disorder and Chest pain, a causal relationship cannot be excluded; however case causality is confounded by the patient's known history of arrhythmia and hypertension. Causality for the event Incorrect route of product administration assessed as not applicable.