Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Bivalent vaccines have undergone several temperature excursions and have been administered to patient; No adverse event; 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 POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 61-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 21-Sep-2022 at 1:00 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 21-Sep-2022 at 1:00 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (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 (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and 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 POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient).    No concomitant medication was reported.  The patient received first, second and third dose on intramuscular route in deltoid region.  The patient received fourth dose on deltoid region.  Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.  Patient received 0.5 of Bivalent vaccine.  No adverse reactions experienced by the patient.  It was unknown if patient had ever been diagnosed or tested positive for COVID-19.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654158, US-MODERNATX, INC.-MOD-2022-654537 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654158:Crosslinked case US-MODERNATX, INC.-MOD-2022-654537:Crosslinked case