Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients; No adverse event; vaccines stored in the refrigerator that underwent several temperature excursions, 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 that underwent several temperature excursions, that were administered to patients), POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients) and NO ADVERSE EVENT (No adverse event) in a 70-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 24-Sep-2022 at 12:59 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 24-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions, 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 that underwent several temperature excursions, that were administered to patients), POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, 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 that underwent several temperature excursions, that were administered to patients) and POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients).    No concomitant medications were reported.   Dose 4 vaccine administered through deltoid.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the Regulatory Authority and made aware of the situation. No adverse reactions reported for any of these patients.  The Nurse reports a temperature excursion that has occurred in a refrigerator at her clinic containing both monovalent and bivalent Moderna Covid-19 vaccines. The Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients.   The Nurse was now calling about Moderna Monovalent and Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.   No information was available on that patients at this time.   It was unknown that the patient ever been diagnosed with/ tested positive for COVID-19.  The patient had received moderna vaccine doses 1, 2, and 3 intramuscularly and at the deltoid site of the body.  No treatment medications were reported.