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; Adult patient received Bivalent booster from vial 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 (Adult patient received Bivalent booster from vial 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 (Adult patient received Bivalent booster from vial 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 (Adult patient received Bivalent booster from vial 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 (Adult patient received Bivalent booster from vial 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).    Concomitant medications were not reported.   The excursion occurred in the refrigerator on 03-Oct-2022 and involved 1 unpunctured red cap vial and 3 unpunctured Bivalent Booster vials.Temperature was reported as Minimum 1.76 Celsius and Maximum 1.97Celsius. Temperature excursion duration was reported as 1 Hour and 40 Minutes. On 03-Oct-2022 it was reported that 11 adult patients had received booster doses from the Bivalent vials on 03-Oct-2022 and 05-Oct-2022. It was also reported that some vials were stored and some were discarded after excursion.          No treatment information was provided by the reporter.  This case was reported for patient 3 of 11 adult patients.