Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago and vaccine was at room temperature for 18 hours after puncture. Dose given in the 18th hour.; No adverse event; 3 patients received Moderna Covid-19 vaccine past its 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients received Moderna Covid-19 vaccine past its 30 day use by date), PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago and vaccine was at room temperature for 18 hours after puncture. Dose given in the 18th hour.) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients received Moderna Covid-19 vaccine past its 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago and vaccine was at room temperature for 18 hours after puncture. Dose given in the 18th hour.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 patients received Moderna Covid-19 vaccine past its 30 day use by date), PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago and vaccine was at room temperature for 18 hours after puncture. Dose given in the 18th hour.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (3 patients received Moderna Covid-19 vaccine past its 30 day use by date) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago and vaccine was at room temperature for 18 hours after puncture. Dose given in the 18th hour.).    No concomitant medications were reported. Previous Moderna Covid-19 booster doses were First booster dose 8-DEC-2022 029H21B Second booster dose 19-MAY-2022 059M21A. No other adverse reactions reported. The adverse event was reported with Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago and vaccine was at room temperature for 18 hours after puncture and dose was given in the 18th hour. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2022: Live significant follow-up received contains product storage error event added.