Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Wrong product administered
Clinical narrative: Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion; Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion; Patient received the 611-year-old Moderna COVID-19 vaccine instead of the 12 plus Moderna COVID-19 vaccine; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), WRONG PRODUCT ADMINISTERED (Patient received the 611-year-old Moderna COVID-19 vaccine instead of the 12 plus Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No Adverse Event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     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 (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), WRONG PRODUCT ADMINISTERED (Patient received the 611-year-old Moderna COVID-19 vaccine instead of the 12 plus Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), WRONG PRODUCT ADMINISTERED (Patient received the 611-year-old Moderna COVID-19 vaccine instead of the 12 plus Moderna COVID-19 vaccine) 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 (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) and WRONG PRODUCT ADMINISTERED (Patient received the 611-year-old Moderna COVID-19 vaccine instead of the 12 plus Moderna COVID-19 vaccine).    No concomitant medications were reported.   The facility had a temperature excursion in the freezer. They had an inspection and saw that their DDL was not recording the temperatures.  At the time of the excursion, the vaccine was in frozen storage. The vaccines were in broken cartons with vial size of 2.5 mL and 5.5 mL.  Because only manual recording was done twice a day, the maximum and minimum temperatures reached by the vials were unknown.  The excursion duration was unknown. The vaccine was returned to the freezer.   The visual inspection showed the vaccine state as still frozen.  The vial underwent temperature excursion for the first time.  No treatment information was provided by the reporter.