Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No Adverse Event; vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients; 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 POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients), 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) in a 62-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 26-Sep-2022 at 1:08 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 dosage form. In 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients). On 26-Sep-2022 at 1:08 PM, 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 NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients), 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) 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 stored in the refrigerator that underwent several temperature excursions, that were administered to patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients).    Concomitant medication information was not provided. The nurse reported about Moderna monovalent and bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022 that were administered to patients. On 07 Sep 2022 vials moved from freezer to refrigerator The patient received first, second and third doses of Moderna COVID-19 vaccine via intramuscular route and site of administration was reported as deltoid muscle. The patient received the fourth dose of Moderna COVID-19 bivalent vaccine on deltoid muscle. No treatment information was provided.   This case was linked to MOD22-025077 (E2B Linked Report).; Sender's Comments:  MOD22-025077: