Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: The vial experienced excursion in the refrigerator on 03OCT2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes; No adverse event; 11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial experienced excursion in the refrigerator on 03OCT2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    In October 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. In October 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The vial experienced excursion in the refrigerator on 03OCT2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial experienced excursion in the refrigerator on 03OCT2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes) 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 POOR QUALITY PRODUCT ADMINISTERED (11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (The vial experienced excursion in the refrigerator on 03OCT2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes).    No concomitant medications were provided. Reporter stated that the excursion occurred in the refrigerator on 03-OCT-2022 involving 3 unpunctured Bivalent Booster vials. Also reported that since 03-OCT-2022 (Excursion Date), 11 adult patients received booster doses from the Bivalent vials on 03-OCT-2022 and 05-OCT-2022. Excursion duration was 1 hour 40 minutes. Reported temperature was minimum 1.76 Celsius & maximum 1.97Celsius. They no longer have these vials. Some were used and some were discarded. Reporter stated that this was the first time these vials experienced excursion. No treatment medications were reported. This case was reported for patient 8th of 11 adult patients.