Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A vial was left out for 70 hours on the 3:06 pm on Friday 8 Jul 2022 and two does were administer), PRODUCT STORAGE ERROR (A vial was left out for 70 hours on the 3:06 pm on Friday 8 Jul 2022 and two does were administer) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 prophylaxis. No Medical History information was reported. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 11-Jul-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (A vial was left out for 70 hours on the 3:06 pm on Friday 8 Jul 2022 and two does were administer). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (A vial was left out for 70 hours on the 3:06 pm on Friday 8 Jul 2022 and two does were administer) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A vial was left out for 70 hours on the 3:06 pm on Friday 8 Jul 2022 and two does were administer), PRODUCT STORAGE ERROR (A vial was left out for 70 hours on the 3:06 pm on Friday 8 Jul 2022 and two does were administer) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (A vial was left out for 70 hours on the 3:06 pm on Friday 8 Jul 2022 and two does were administer) and PRODUCT STORAGE ERROR (A vial was left out for 70 hours on the 3:06 pm on Friday 8 Jul 2022 and two does were administer). No Concomitant medications were provided. The patient was not diagnosed with COVID-19 or was tested positive for COVID-19. It was reported that a vial was left out for 70 hours on the 3:06 pm on Friday 8 Jul 2022 and two does were administer on the 11 Jul 2022 at 9:30AM  and 1 PM. It was unknown when the vial was initially stored in the refrigerator and was first punctured. Vial was stored at RT post puncture and undergone temperature excursions. Total amount of time vial was exposed to room temperature range (8 degree to 25 degree C which was equal to 46 degree to 77 degree F) was 70 hours. Storage condition at the time of the excursion was room temperature. It was unknown maximum or minimum temperatures reached and excursion duration was 70 hours. It was unknown when vial was moved from freezer to refrigerator and upon visual inspection noting any vaccine state change. It was reported that no adverse event was occurred. No treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2022: Follow up received includes: Case type updated from invalid to valid, reporter details, patient demographics, suspect details added and updated narrative.