Age: 47.0
Sex: M
Vaccine: COVID19-2
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 patient; No adverse event; Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patient; 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 patient), POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 47-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 24-Sep-2022 at 12:23 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 24-Sep-2022 at 12:23 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patient). 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 patient) 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 patient), POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patient) 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 patient) and POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patient).    Concomitant medications were not provided.  Patient took first, second and third dose through intramuscularly at deltoid region. Dose 4 vaccine was 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 was 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 monovalent and bivalent vaccines had that underwent several temperature excursions going back to August 2022.  It was unknown if the patient had ever been diagnosed with or tested positive for COVID-19.  No treatment medications were reported.