Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient; No adverse event; Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient) and NO ADVERSE EVENT (No adverse event) in a 60-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 22-Sep-2022 at 5:39 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 22-Sep-2022 at 5:39 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and 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 (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient).    No concomitant product use was reported.  It was unknown whether the patient was diagnosed/tested positive for COVID-19.  The patient received previous 3 dose of vaccine intramuscular in deltoid.  Anatomical location of bivalent vaccine was reported as deltoid.  It was reported that the vaccines had undergone several temperature excursions in August 2022.  Refrigeration excursions identified and vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. No adverse reactions reported for any patient at the time of report.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-654158, US-MODERNATX, INC.-MOD-2022-654537 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654158:Master Case (Monovalent) US-MODERNATX, INC.-MOD-2022-654537:Master Case (Bivalent)