Reporte zur Charge 047C21A / 23C21

Symptomtext

patient received a re frozen dose of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (patient received a re frozen dose of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A / 23C21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient received a re frozen dose of the vaccine). At the time of the report, PRODUCT STORAGE ERROR (patient received a re frozen dose of the vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. There were two different lot numbers involved in the incident: 047C21A and 23C21A which were all booster doses. The patient received booster doses that were done from vaccine that was thawed, inadvertently refrozen, and then thawed again before administration. Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Non-significant follow up appended On 05-Nov-2021: Follow up contains significant information, Suspect batch number was added.