Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine was stored in refrigerator on 7 sep 2022 and minimum temperature reached 1.04 degrees celsius and administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was undergone temperature excursion and was adminstered) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Sep-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine was stored in refrigerator on 7 sep 2022 and minimum temperature reached 1.04 degrees celsius and administered to patient) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was undergone temperature excursion and was adminstered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine was stored in refrigerator on 7 sep 2022 and minimum temperature reached 1.04 degrees celsius and administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was undergone temperature excursion and was adminstered) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine was stored in refrigerator on 7 sep 2022 and minimum temperature reached 1.04 degrees celsius and administered to patient) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was undergone temperature excursion and was adminstered).    No concomitant medication was provided.  It was reported that 2 temperature excursions were happened.   It was reported that on 7 Sep 2022, they received a box of frozen vials that were placed on the data logger probe causing the temperature to drop blocking the rest of the vaccines.   Minimum temperature reached was about 1.04 degrees celsius and the excursion duration was 35 minutes adjusted back to normal temperature.   Reportedly, temperature excursion happened with bivalent product and the storage condition at the time of the excursion was refrigerated storage invloved unbroken carton with the vial size 2.5 ml.   Date the vial moved from freezer to refrigerator was not provided.  It was reported that they were stored now at refrigerator but already used and the visual inspection noted that any vaccine state change was thawed.  Proposed desired use by date (date of vaccination clinic, patient appointments, etc. that HCP would like vaccine administered from the vials in question) was not applicable.    The vial did not undergo any previous temperature excursions.  Treatment medication was not provided by the reporter.