Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; Vaccine that underwent temperature excursions could have been administered to patient; Refrigeration excursions identified/ Vaccine that underwent temperature excursions could have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/ Vaccine that underwent temperature excursions could have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Vaccine that underwent temperature excursions could have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 44-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.     It was unknown if patient was ever been diagnosed with/ tested positive for COVID-19.     On 15-Sep-2022 at 3:47 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. In 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/ Vaccine that underwent temperature excursions could have been administered to patient). On 15-Sep-2022 at 3:47 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine that underwent temperature excursions could have been administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/ Vaccine that underwent temperature excursions could have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Vaccine that underwent temperature excursions could 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 (Refrigeration excursions identified/ Vaccine that underwent temperature excursions could have been administered to patient) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine that underwent temperature excursions could have been administered to patient).    No concomitant medications were reported.  It was reported that refrigeration excursions was 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. The Nurse called for a clinic that she was assisting. 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 Aug-2022. The Moderna bivalent vaccines had undergone several temperature excursions and may have been administered to the patients.  The patient administered the dose 4 vaccine in the deltoid (unspecified location) muscle.  No adverse reactions reported for the patient.  No treatment medications were reported.   This case was linked to MOD22-025077 (Linked Report).; Sender's Comments:  MOD22-025077: