Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccines stored in the refrigerator underwent several temperature excursions, and that were administered to patients; No adverse event; Vaccines stored in the refrigerator underwent several temperature excursions, and that were administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions, and that were administered to patients), POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions, and that were administered to patients) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     Allergies to medications, food, and other products was not applicable. It was unknown if patient ever been diagnosed with/tested positive for COVID-19.     On 25-Sep-2022 at 4:29 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 25-Sep-2022 at 4:29 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions, and that were administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions, and that were administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions, and that were administered to patients), POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions, and that were administered to patients) 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 (Vaccines stored in the refrigerator underwent several temperature excursions, and that were administered to patients) and POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions, and that were administered to patients).    On an unknown dates, patient had received dose 1, dose 2, dose 3 of Moderna vaccines. Route was Intramuscular and body site was deltoid for all three doses. Patient had received on deltoid body site for dose 4. The volume of vaccine patient received was 0.5 with an unknown unit.   No concomitant medication was provided.  It was reported that refrigeration excursions identified, state vaccine was housed in these units.  Manufactures were notified and the state department and made aware of the situation. The vials were Stored in refrigerator at the time of the excursion. There were 2 unbroken cartons and 20 vials. Two different lot numbers AS1412B and 057A22A were reported. The vials moved from freezer to refrigerator on 7-SEP-2022. The clinic which the reported was working had a similar issue with vaccines stored in the freezer. Vaccines stored in the refrigerator that underwent several temperature excursions on August 2022.  It was reported that no adverse reactions were reported to reporter's knowledge for any patients.  Treatment medication was not provided by the reporter.