Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 100 bivalent doses were administered post temperature excursion/temperature excursion which occurred on 13Oct2022 involving both the bivalent and monovalent stored in the freezer; 100 bivalent doses were administered post temperature excursion/temperature excursion which occurred on 13Oct2022 involving both the bivalent and monovalent stored in the freezer; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (100 bivalent doses were administered post temperature excursion/temperature excursion which occurred on 13Oct2022 involving both the bivalent and monovalent stored in the freezer), POOR QUALITY PRODUCT ADMINISTERED (100 bivalent doses were administered post temperature excursion/temperature excursion which occurred on 13Oct2022 involving both the bivalent and monovalent stored in the freezer) 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)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (100 bivalent doses were administered post temperature excursion/temperature excursion which occurred on 13Oct2022 involving both the bivalent and monovalent stored in the freezer), POOR QUALITY PRODUCT ADMINISTERED (100 bivalent doses were administered post temperature excursion/temperature excursion which occurred on 13Oct2022 involving both the bivalent and monovalent stored in the freezer) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (100 bivalent doses were administered post temperature excursion/temperature excursion which occurred on 13Oct2022 involving both the bivalent and monovalent stored in the freezer), POOR QUALITY PRODUCT ADMINISTERED (100 bivalent doses were administered post temperature excursion/temperature excursion which occurred on 13Oct2022 involving both the bivalent and monovalent stored in the freezer) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (100 bivalent doses were administered post temperature excursion/temperature excursion which occurred on 13Oct2022 involving both the bivalent and monovalent stored in the freezer) and POOR QUALITY PRODUCT ADMINISTERED (100 bivalent doses were administered post temperature excursion/temperature excursion which occurred on 13Oct2022 involving both the bivalent and monovalent stored in the freezer).    Concomitant medications were not reported.  The temperature excursion which occurred on 13Oct2022 involving both the bivalent stored in the freezer, first temperature excursion. Maximum temperature reached was minus 12.04C. All of the 100 bivalent doses were administered post temperature excursion. No adverse events reported by patients so far.   Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-686081 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-686081:Monovalent