Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refrigeration excursions identified/undergone several temperature excursions; No adverse event; vaccines had undergone several temperature excursions and may have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (vaccines had undergone several temperature excursions and may have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 57-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 23-Sep-2022 at 11:56 AM, 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 23-Sep-2022 at 11:56 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccines had undergone several temperature excursions and may have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (vaccines had undergone several temperature excursions and may have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/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 had undergone several temperature excursions and may have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/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 COVID-19  vaccines. Route was Intramuscular and body site was deltoid for all three doses. Patient had received on deltoid body site for dose 4.  The nurse reported that vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.  It was reported that refrigeration excursions identified, state vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.  It was reported that no adverse reactions were reported to their knowledge for any patients.  Treatment medication was not provided by the reporter