Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022; No adverse event; Dose administered after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022), EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 003K21-2A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Dose: 1, time: 04:00 PM, lot number: EN5318, route: intramuscular, body site: left arm, volume: 0.3 ML) on 02-Feb-2021, COVID-19 Vaccine (Dose: 2, time: 02:21 PM, lot number: EL9264, route: intramuscular, body site: left arm, volume: 0.3 ML) on 23-Feb-2021, COVID-19 Vaccine (Dose: 3, time: 10:10 AM, lot number: FF8839, route: intramuscular, body site: left arm and volume: 0.3 ML) on 06-Oct-2021. Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine, COVID-19 Vaccine and COVID-19 Vaccine. Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN, HYDROCHLOROTHIAZIDE and METOPROLOL for an unknown indication.    On 26-May-2022 at 10:37 AM, the patient received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .25 milliliter. On 26-May-2022 at 10:37 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022), EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022).    The patient had been never diagnosed with/tested positive for COVID-19. Acute illnesses at the time of vaccination and up to one month before was reported as unknown.  The vial was initially stored in the refrigerator on 21-Jan-2022. Number of vials involved was 5. The vial did not undergo any temperature excursions. The reporter thought that Moderna had an extension like Pfizer, and it would expire on the 13-Jul-2022 but it was expired on the 13-May-2022, they realize this on the 08-Jun-2022. The used vials were placed in the refrigerator on the same day of administration on 26-May-2022. The event did not cause the patient to seek medical care. It was unknown whether there were any other potential causes for the event. It was unknown whether patient experienced a similar event in the past.   No treatment medication reported by reporter.