Sex: F
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 monovalent Moderna COVID-19 vaccine instead of the 12 plus bivalent 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 monovalent Moderna COVID-19 vaccine instead of the 12 plus bivalent 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 monovalent Moderna COVID-19 vaccine instead of the 12 plus bivalent 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 monovalent Moderna COVID-19 vaccine instead of the 12 plus 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 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 monovalent Moderna COVID-19 vaccine instead of the 12 plus bivalent Moderna COVID-19 vaccine).    Concomitant medications were not reported.  The patient received booster dose of Moderna vaccine.The facility had a temperature excursion in the freezer. They had an inspection and had seen that their DDL was not recording the temperatures The storage condition was reported as frozen at the time of the excursion. The vials were within unbroken cartons and were of the sizes 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.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2022: Live follow-up received, number of patients updated. On 09-Nov-2022: Live follow-up received, number of patients who had received the vaccine was updated. On 09-Nov-2022: Live follow-up received, number of patients updated. On 09-Nov-2022: Live follow-up received, number of patients were updated and updated narrative.