Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: A dose of the Moderna Covid-19 Vaccine that was administered more than 30 days after the vial was first removed from frozen storage/1 possible refreeze occurred; A dose of the Moderna Covid-19 Vaccine that was administered more than 30 days after the vial was first removed from frozen storage/3 doses administered past 30 day use by date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of the Moderna Covid-19 Vaccine that was administered more than 30 days after the vial was first removed from frozen storage/3 doses administered past 30 day use by date) and PRODUCT STORAGE ERROR (A dose of the Moderna Covid-19 Vaccine that was administered more than 30 days after the vial was first removed from frozen storage/1 possible refreeze occurred) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of the Moderna Covid-19 Vaccine that was administered more than 30 days after the vial was first removed from frozen storage/3 doses administered past 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (A dose of the Moderna Covid-19 Vaccine that was administered more than 30 days after the vial was first removed from frozen storage/1 possible refreeze occurred). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of the Moderna Covid-19 Vaccine that was administered more than 30 days after the vial was first removed from frozen storage/3 doses administered past 30 day use by date) and PRODUCT STORAGE ERROR (A dose of the Moderna Covid-19 Vaccine that was administered more than 30 days after the vial was first removed from frozen storage/1 possible refreeze occurred) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided It was reported that a pack of 10 vials arrived on 10-Feb-2022 at a temperature of 0C to 1C. The Department of Health had removed them from frozen storage that morning & shipped them to them in non-frozen packaging. Their procedure had always been to put newly received vials in the freezer, which they did. The vial was stored frozen from that point on until the day of administration. It was reported Number of doses/vials administered included for 3 patients, one on 17-Mar-2022 and two on 24-Mar-2022. The vial was initially stored in the refrigerator on 10-Feb-2022  and use by date was given as 12-Mar-2022. Treatment information was not provided. Upon further detailed review of the patient log: Reporter found 3 patients ( not 1 as he told him over the phone) given the vaccination from this lot out the 30 days range of 3/12/2022 expiration date ( 30 days from the onsite of temperature excursion.   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2022: Follow-up received contains Non Significant information -Patient Info updated(3 patients),