Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Excursion temperature was between -15 degree C and -2 degree C; Product Storage Error; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion temperature was between -15 degree C and -2 degree C), PRODUCT STORAGE ERROR (Product Storage Error) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     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 (Excursion temperature was between -15 degree C and -2 degree C), PRODUCT STORAGE ERROR (Product Storage Error) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion temperature was between -15 degree C and -2 degree C), PRODUCT STORAGE ERROR (Product Storage Error) 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 (Excursion temperature was between -15 degree C and -2 degree C) and PRODUCT STORAGE ERROR (Product Storage Error).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Unopened Carton To the best of our knowledge, first time this excursion happened. Intended vials to be frozen. Excursion temperature was between -15 degree C and -2-degree C. Not sure how long the excursion lasted. The minimum temperature reached in this excursion was 15-degree C. -2 degree C was the maximum temperature reached in this excursion. 30 days was the duration of the excursion. 10 vials were affected by this excursion. In 6 days or more intend to use these vials. The pharmacist states another entity was telling him to report it. He doesn't have an actual excursion. He explains that when they first started Moderna vaccine program, which was over 2 years ago, they purchased a stand-alone fridge and were told they didn't need a stand-alone freezer. He understands that the vaccines need to be in a stand-alone freezer unit. The pharmacist was wondering if he needs to re-vaccinate the hundreds of patients that he already vaccinated. He thought it was unnecessary. Going forward, he immediately ordered the stand-alone freezer and the additional DDLs. The pharmacist states he cannot confirm whether the vaccines in his fridge-freezer unit ever thawed, but every time they vaccinate patients, the vaccines are frozen.  HCP confirms that he has both monovalent and bivalent vaccines.  Concomitant medication not reported. Treatment medication not reported.