Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patients; No adverse event; Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 69-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.     No Medical History information was reported.    On 23-Sep-2022 at 1:59 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 23-Sep-2022 at 1:59 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been 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 (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patients).    Concomitant product use was not provided by the reporter.  Dose 4 vaccine administered at deltoid region.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. No adverse reactions reported.  The nurse reported a temperature excursion that had occurred in a refrigerator at her clinic containing both monovalent and bivalent Moderna Covid-19 vaccines. The Moderna and Bivalent vaccines had that underwent several temperature excursions going back to August 2022.  It was unknown that the patient ever been diagnosed with/ tested positive for COVID-19.  Treatment information was not provided.