Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored post puncture in fridge; No Adverse Event; Bivalent vaccine administered after more than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine administered after more than 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was stored post puncture in fridge) and NO ADVERSE EVENT (No Adverse Event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 010H22A, 051B22A, 067H21A and 067F21A) for COVID-19 vaccination.     Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included COVID-19 in January 2022 and Post-COVID-19 syndrome in June 2022. Concurrent medical conditions included Seasonal allergy, Hypothyroidism, Dyslipidemia, Hypertension, Obstructive sleep apnea syndrome, Left ventricular hypertrophy, Reflux gastritis, Tachycardia and Morbid obesity. Concomitant products included LEVOTHYROXINE, TIRZEPATIDE (MOUNJARO), DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ), MONTELUKAST SODIUM (SINGULAIR), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), METOPROLOL TARTRATE and ONDANSETRON (ZOFRAN [ONDANSETRON]) for an unknown indication.   On 19-Nov-2021, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Dec-2021, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2022 at 9:08 AM, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2022 at 9:08 AM, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine administered after more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored post puncture in fridge) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine administered after more than 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was stored post puncture in fridge) 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 EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine administered after more than 12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was stored post puncture in fridge). Reporter reported that the vial was individual vial and size was 2.5 ml. The Vial was first punctured on 08-Nov-2022 at 8:23 am. The vial was stored post puncture in fridge. Total amount of time the vial exposed to room temperature range (8° to 25°C= 46° to 77°F) was not more than 1 minute. The vial did not undergo any temperature excursions. Treatment information was not provided. This case was linked to MOD-2022-670570 (Patient Link).