Reporte zur Charge 058E21n

Symptomtext

Dose administered after exposure to room temperature >24 hours/administered with the vaccine that was supposed to be thrown away yesterday, 07Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours/administered with the vaccine that was supposed to be thrown away yesterday, 07Sep2021) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours/administered with the vaccine that was supposed to be thrown away yesterday, 07Sep2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours/administered with the vaccine that was supposed to be thrown away yesterday, 07Sep2021) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was given by reporter. No treatment medication was given by reporter Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Added reporter information: first name, last name, occupation, reporter type, address, postal code.added patient detail: Date of birth, pregnancy status no. On 14-Sep-2021: Non-significant follow-up appended; Sender's Comments: This case concerns 30 -year-old female patient with no medical history, who experienced the unexpected event of Expired product administered. First dose of mRNA-1273, Moderna COVID-19 was administered after exposure to room temperature more than 24 hours. Event seriousness assessed as per Regulatory Authority reporting. The rechallenge was considered unknown. The reporter did not provide a causality assessment. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.