Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Wrong product administered
Clinical narrative: Patients received the vaccination after a temperature excursion; Patients received the vaccination 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 (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination 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 an adult male patient 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 (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination 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 (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination 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 (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination 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 product was reported.  It was reported that the facility had a temperature excursion in the freezer, the DDL was not recording the temperatures. Patient received the vaccine after a temperature excursion. Storage condition at the time of the excursion was frozen. Temperature was unknown and only manual recording of temperature was done twice a day. Vials were within unbroken cartons and were of the size 2.5 ml and 5.5 ml. The vials were returned to the freezer and were still frozen.  No treatment information was reported.