Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Storage condition at the time of the excursion: frozen storage / refrigerated storage / ambient room temperature: transport temparmour - HCP stated that the vials were stored in a cooler; No adverse event; HCP states that the excursion occurred on 31-May-2023 and the vaccine was administered to 4 patients post excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP states that the excursion occurred on 31-May-2023 and the vaccine was administered to 4 patients post excursion), PRODUCT STORAGE ERROR (Storage condition at the time of the excursion: frozen storage / refrigerated storage / ambient room temperature: transport temparmour - HCP stated that the vials were stored in a cooler) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-May-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-May-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP states that the excursion occurred on 31-May-2023 and the vaccine was administered to 4 patients post excursion). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Storage condition at the time of the excursion: frozen storage / refrigerated storage / ambient room temperature: transport temparmour - HCP stated that the vials were stored in a cooler) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP states that the excursion occurred on 31-May-2023 and the vaccine was administered to 4 patients post excursion), PRODUCT STORAGE ERROR (Storage condition at the time of the excursion: frozen storage / refrigerated storage / ambient room temperature: transport temparmour - HCP stated that the vials were stored in a cooler) 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 states that the excursion occurred on 31-May-2023 and the vaccine was administered to 4 patients post excursion) and PRODUCT STORAGE ERROR (Storage condition at the time of the excursion: frozen storage / refrigerated storage / ambient room temperature: transport temparmour - HCP stated that the vials were stored in a cooler).    No concomitant medications were reported.  It was reported that 10 doses of Moderna of lot 022H22A, got out of range (46.4 degrees) for 5 minutes on 31-May-2023. The HCP stated that the excursion occurred on 31-May-2023 and the vaccine was administered to 4 patients post excursion. No adverse reactions have been reported by any patients. It was dose number 6 for all patients. HCP further provided the clarifications that Storage condition at the time of the excursion: frozen storage / refrigerated storage / ambient room temperature: transport temparmour - HCP stated that the vials were stored in a cooler. They were thawed vials and were stored in the refrigerated temperature range in the cooler.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2023: Significant follow-up appended: Patient details updated and narrative updated.