Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03-Oct-2022; No adverse event; 11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03-Oct-2022; 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 03-Oct-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03-Oct-2022) 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 03-Oct-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03-Oct-2022) 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 03-Oct-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03-Oct-2022) 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 03-Oct-2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03-Oct-2022).    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. 3 Patients received Monovalent primary doses from the red cap vial on 19-Oct-2022.  It was reported that some of the vials were used and some were discarded.                             No treatment information was reported.  This case was reported for patient 4 of 11 adult patients who received booster doses from the Bivalent vials.