Sex: F
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 after a temperature excursion; Received the 611-year-old Moderna COVID-19 vaccine instead of the 12+ Moderna COVID-19 vaccine/received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine; Facility had a temperature excursion in the freezer; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent after a temperature excursion), WRONG PRODUCT ADMINISTERED (Received the 611-year-old Moderna COVID-19 vaccine instead of the 12+ Moderna COVID-19 vaccine/received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer) 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 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 Moderna COVID-19 Vaccine Monovalent after a temperature excursion), WRONG PRODUCT ADMINISTERED (Received the 611-year-old Moderna COVID-19 vaccine instead of the 12+ Moderna COVID-19 vaccine/received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent after a temperature excursion), WRONG PRODUCT ADMINISTERED (Received the 611-year-old Moderna COVID-19 vaccine instead of the 12+ Moderna COVID-19 vaccine/received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer) 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 Moderna COVID-19 Vaccine Monovalent after a temperature excursion), WRONG PRODUCT ADMINISTERED (Received the 611-year-old Moderna COVID-19 vaccine instead of the 12+ Moderna COVID-19 vaccine/received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Facility had a temperature excursion in the freezer).    No concomitant product reported by reporter.  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.  Vaccines in unbroken cartons were under frozen storage at the time of the excursion with vial size of 2.5 ml and 5.5 ml. Maximum or minimum temperature reached was unknown and only had manual twice a day recording and duration of excursion was unknown. Vials were returned to freezer and were still frozen.  No treatment medication reported by reporter. Case included information of 1st out of 15 patients.   This case was linked to US-MODERNATX, INC.-MOD-2022-670319 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2022: Live follow-up included updated number of patients. On 09-Nov-2022: Live follow-up included updated number of patients. On 09-Nov-2022: Live follow-up included updated number of patients. On 09-Nov-2022: Live follow-up included updated number of patients.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-670319:same reporter