Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: HCP stated some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during 2 days and 11 hours.; No adverse event; HCP stated some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during 2 days and 11 hours.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during 2 days and 11 hours.), PRODUCT STORAGE ERROR (HCP stated some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during 2 days and 11 hours.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     It was unknown whether the patient had any relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On 05-Jun-2023, 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 05-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during 2 days and 11 hours.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (HCP stated some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during 2 days and 11 hours.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during 2 days and 11 hours.), PRODUCT STORAGE ERROR (HCP stated some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during 2 days and 11 hours.) 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 (HCP stated some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during 2 days and 11 hours.) and PRODUCT STORAGE ERROR (HCP stated some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during 2 days and 11 hours.).    It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine or not. The dosage text of the suspect was reported as unknown. No concomitant medication was reported. It was reported that the maximum  temperature reached was 57A °F. This was the first and only excursion. Two doses were administered on 05-JUN-2023 after the excursion had happened. No adverse events were reported.  No treatment medication was reported. This case contains information for the 1st of 2 patients described by the reporter.