Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | N/A | 3052550 | IM / LA |
Timeline of Events 5:11 PM ? Employee removed two boxes of Moderna Spikevax prefilled syringes from frozen storage (-15°C to -50°C) and placed them into the refrigerator (2°C?8°C) for thawing. She labeled the boxes with an incorrect ?ready-to-use? time of 5:51 PM (40 minutes after removal). Per the XO COVID-19 Vaccine Reference Guide, thawing in the refrigerator requires 2 hours and 40 minutes for a carton of 10 syringes. Therefore, the correct ?ready-to-use? time should have been 7:51 PM. 5:55 PM ? The Moderna Spikevax dose was administered to the patient by employee, approximately 44 minutes after being placed in the refrigerator (well before the required thaw period). During administration: employee met injection resistance and could not fully discharge the syringe. Upon withdrawing the syringe, she noted that the vaccine appeared partially frozen (approximately 1 inch of frozen content remaining). Some vaccine liquid came into contact with her finger during inspection. 6:05 PM ? Employee reported the incident to the MA Lead. Employee, who had assisted in preparing the vaccines (Flu, COVID-19, and HPV #1), confirmed she and employee had verified the syringes together prior to administration. Deviation from Manufacturer and CDC Protocol According to Moderna and CDC storage and handling guidance: A prefilled Spikevax syringe requires at least 1 hour and 40 minutes to thaw in the refrigerator (2°C?8°C) before administration. The administered dose was thawed for only 44 minutes, meaning it was not fully thawed and therefore administered outside of manufacturer protocol. This constitutes a handling deviation.