Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Wrong product administered
Clinical narrative: Patient received the vaccine after a temperature excursion/facility had a temperature excursion in the freezer; Patient received the vaccine after a temperature excursion/facility had a temperature excursion in the freezer; Patient received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine/ Patients 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 vaccine after a temperature excursion/facility had a temperature excursion in the freezer), POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccine after a temperature excursion/facility had a temperature excursion in the freezer), WRONG PRODUCT ADMINISTERED (Patient received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine/ Patients 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 female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the vaccine after a temperature excursion/facility had a temperature excursion in the freezer), POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccine after a temperature excursion/facility had a temperature excursion in the freezer), WRONG PRODUCT ADMINISTERED (Patient received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine/ Patients 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 vaccine after a temperature excursion/facility had a temperature excursion in the freezer), POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccine after a temperature excursion/facility had a temperature excursion in the freezer), WRONG PRODUCT ADMINISTERED (Patient received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine/ Patients 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 (Moderna COVID-19 Vaccine) (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 vaccine after a temperature excursion/facility had a temperature excursion in the freezer), POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccine after a temperature excursion/facility had a temperature excursion in the freezer) and WRONG PRODUCT ADMINISTERED (Patient received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine/ Patients received the 6-11-year-old Moderna COVID-19 vaccine instead of the 12 plus Moderna COVID-19 vaccine).    No concomitant product was reported. 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. Currently, the vials were returned to the freezer and were still frozen. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2022: Follow-up received included updated narrative. On 09-Nov-2022: Follow-up received included updated number of patients.