Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Wrong product administered
Clinical narrative: Patient received the vaccination after a temperature excursion; Patient received the vaccination after a temperature excursion/Facility had a temperature excursion in the freezer; Received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the vaccination after a temperature excursion/Facility had a temperature excursion in the freezer), WRONG PRODUCT ADMINISTERED (Received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the vaccination after a temperature excursion/Facility had a temperature excursion in the freezer), WRONG PRODUCT ADMINISTERED (Received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the vaccination after a temperature excursion/Facility had a temperature excursion in the freezer), WRONG PRODUCT ADMINISTERED (Received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent 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 POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the vaccination after a temperature excursion/Facility had a temperature excursion in the freezer) and WRONG PRODUCT ADMINISTERED (Received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine).    No concomitant drug information was provided. Patient received booster dosage . It was reported by the reporter that 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 excursion, the products were in frozen storage as unbroken cartons. However, the excursion duration and temperature were unknown. Both vial sizes of 2.5ml and 5.5ml were affected. At the time of report the product was returned to the freezer. A total of 15 patients had received the reported vaccine. Case included information of 7th out of 15 patients. In present case Patients who received the vaccination at the facility in contact 1. No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2022: Live follow-up has been appended in which  number of patients was updated. On 09-Nov-2022: Live follow-up has been appended in which number of patients who had received the vaccine was updated. On 09-Nov-2022: Live follow-up has been appended in which number of patients updated. On 09-Nov-2022: Live follow-up has been appended in which  narrative and number of patients updated were updated