Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Vaccines administered after above 24 hours exposure to ambient room temperature; The total time that this refrigerated Moderna vaccine spent out of range was 27.5 hours above 8 degrees celsius; Max temp was 12.6 degrees celsius/ total time above 8 degrees celsius was 27 hours 30 minutes/this excursion was not caught until after all the vaccine had been administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after above 24 hours exposure to ambient room temperature), PRODUCT STORAGE ERROR (The total time that this refrigerated Moderna vaccine spent out of range was 27.5 hours above 8 degrees celsius), PRODUCT TEMPERATURE EXCURSION ISSUE (Max temp was 12.6 degrees celsius/ total time above 8 degrees celsius was 27 hours 30 minutes/this excursion was not caught until after all the vaccine had been administered) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 056A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered after above 24 hours exposure to ambient room temperature), PRODUCT STORAGE ERROR (The total time that this refrigerated Moderna vaccine spent out of range was 27.5 hours above 8 degrees celsius), PRODUCT TEMPERATURE EXCURSION ISSUE (Max temp was 12.6 degrees celsius/ total time above 8 degrees celsius was 27 hours 30 minutes/this excursion was not caught until after all the vaccine had been administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after above 24 hours exposure to ambient room temperature), PRODUCT STORAGE ERROR (The total time that this refrigerated Moderna vaccine spent out of range was 27.5 hours above 8 degrees celsius), PRODUCT TEMPERATURE EXCURSION ISSUE (Max temp was 12.6 degrees celsius/ total time above 8 degrees celsius was 27 hours 30 minutes/this excursion was not caught until after all the vaccine had been administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccines administered after above 24 hours exposure to ambient room temperature), PRODUCT STORAGE ERROR (The total time that this refrigerated Moderna vaccine spent out of range was 27.5 hours above 8 degrees celsius) and PRODUCT TEMPERATURE EXCURSION ISSUE (Max temp was 12.6 degrees celsius/ total time above 8 degrees celsius was 27 hours 30 minutes/this excursion was not caught until after all the vaccine had been administered).    No concomitant medications were reported. Reporter was writing regarding an excursion that happened at a facility. The total time that this refrigerated Moderna vaccine spent out of range was 27.5 Hours above 8 C. Unfortunately, this excursion was not caught until after all the vaccine had been administered so inquired to see if there was any additional information that could potentially support the efficacy of this vaccine after 27.5 hours above 8 C. This vaccine had no prior excursions. First reading and evaluation was captured on 20-Jun-2022 9:04:00 AM Last reading and evaluation was captured on 15-Aug-2022 2:04:00 PM Lowest temperature: 2.8 °C on 21-Jun-2022 7:19:00 PM Highest temperature: 12.6 °C on 30-Jun-2022 7:04:00 AM No treatment drugs were reported.