Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered, Product storage error, Product temperature excursion issue
Clinical narrative: 09Mar2022 stored in the refrigerator, first punctured on 09Mar2022, vial stored room temperature for about 24 hours, on 10Mar2022 administration of vaccine; 09Mar2022 stored in the refrigerator, first punctured on 09Mar2022, vial stored room temperature for about 24 hours, on 10Mar2022 administration of vaccine; Patient received a 4th dose; Dose was administered 12 hours post puncture to the patient/Dose was administered about 24 hours post puncture being at RT; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received a 4th dose), EXPIRED PRODUCT ADMINISTERED (Dose was administered 12 hours post puncture to the patient/Dose was administered about 24 hours post puncture being at RT), PRODUCT STORAGE ERROR (09Mar2022 stored in the refrigerator, first punctured on 09Mar2022, vial stored room temperature for about 24 hours, on 10Mar2022 administration of vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (09Mar2022 stored in the refrigerator, first punctured on 09Mar2022, vial stored room temperature for about 24 hours, on 10Mar2022 administration of vaccine) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2022, the patient experienced EXTRA DOSE ADMINISTERED (Patient received a 4th dose) and EXPIRED PRODUCT ADMINISTERED (Dose was administered 12 hours post puncture to the patient/Dose was administered about 24 hours post puncture being at RT). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (09Mar2022 stored in the refrigerator, first punctured on 09Mar2022, vial stored room temperature for about 24 hours, on 10Mar2022 administration of vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (09Mar2022 stored in the refrigerator, first punctured on 09Mar2022, vial stored room temperature for about 24 hours, on 10Mar2022 administration of vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (Patient received a 4th dose), EXPIRED PRODUCT ADMINISTERED (Dose was administered 12 hours post puncture to the patient/Dose was administered about 24 hours post puncture being at RT), PRODUCT STORAGE ERROR (09Mar2022 stored in the refrigerator, first punctured on 09Mar2022, vial stored room temperature for about 24 hours, on 10Mar2022 administration of vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (09Mar2022 stored in the refrigerator, first punctured on 09Mar2022, vial stored room temperature for about 24 hours, on 10Mar2022 administration of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported. The vial was first punctured on 09-Mar-2022. The vial was stored post puncture for about 24 hours. The vial was exposed to room temperature of maximum 70 degree Fahrenheit, minimum of 68 degree Fahrenheit for about 24 hours. The temperature excursion duration was 24 hours.