Age: 74.0
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 (Moderna Covid-19 vaccine administered to a patient past the 30 day use by date/Dose was administered greater than 12 hours after the vial had been punctured), PRODUCT STORAGE ERROR (vaccine was punctured on 16JUN2022, stored in fridge post puncture and administered on 09Aug2022) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058A22-2A, 939906 and 021B21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered to a patient past the 30 day use by date/Dose was administered greater than 12 hours after the vial had been punctured). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was punctured on 16JUN2022, stored in fridge post puncture and administered on 09Aug2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered to a patient past the 30 day use by date/Dose was administered greater than 12 hours after the vial had been punctured), PRODUCT STORAGE ERROR (vaccine was punctured on 16JUN2022, stored in fridge post puncture and administered on 09Aug2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered to a patient past the 30 day use by date/Dose was administered greater than 12 hours after the vial had been punctured) and PRODUCT STORAGE ERROR (vaccine was punctured on 16JUN2022, stored in fridge post puncture and administered on 09Aug2022). No concomitant medications were provided by the reporter. The vial was initially stored in the refrigerator on 05-JUN-2022 and the use by date was 05-JUL-2022. The Moderna Covid-19 vaccine was punctured on 16-JUN-2022 15:10 (3:10PM) and the vial was stored in fridge post puncture. The dose was administered on 09-AUG-2022. The vial did not undergo any temperature excursions. The vial was not exposed to room temperature greater than 24 hours. No Adverse reactions or Side Effects were reported post first, second and first booster dose. No treatment medications were provided by the reporter.