Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refrigeration excursions identified/vaccines have undergone several temperature excursions; No adverse event; vaccines undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 73-year-old male 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.     No Medical History information was reported.    On 16-Sep-2022 at 2:06 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 16-Sep-2022 at 2:06 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) 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 POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions).    No concomitant medication was provided.  The patient had ever been diagnosed with/ tested positive for COVID-19 was unknown.  On an unknown date, 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.   Date vial was moved from freezer to refrigerator on 7-Sep-2022. The 2 unbroken cartons 20 vials.  It was reported that refrigeration excursions identified, vaccine was housed in these units. There were excursions noted. Manufactures were notified and the department and made aware of the situation. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. It was reported that no adverse reactions were reported to their knowledge for any patients.  Treatment medication was not provided by the reporter