Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date; Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Batch number: EN3207) on 25-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer.    On 04-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 04-May-2022/ Dose administered after 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Patient had received 1st booster dose on 04 May 2022.  It was reported by pharmacist, the vaccine coordinator in their health care facility, that they inadvertently administered an expired dose of the Moderna Covid-19. Post further investigation of the issue, pharmacist identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number 084J21A was received and placed in the fridge initially on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA. The vial did not undergo any temperature excursions. The patient did not report any adverse reaction to the health care professional's knowledge.  Treatment information was not provided by the reporter.