Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Wrong product administered
Clinical narrative: On 30Dec2022, they administered a Moderna Bivalent dose to a patient, 26 hours after exposure to room temperature/ Dose administered after exposure to room temperature more than 24 hours; No Adverse Event; On 30Dec2022, they administered a Moderna Bivalent dose to a patient, 26 hours after exposure to room temperature/ Dose administered after exposure to room temperature more than 24 hours; administered the Bivalent as the patient's initial primary dose instead of the Monovalent vaccine/; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (On 30Dec2022, they administered a Moderna Bivalent dose to a patient, 26 hours after exposure to room temperature/ Dose administered after exposure to room temperature more than 24 hours), WRONG PRODUCT ADMINISTERED (administered the Bivalent as the patient's initial primary dose instead of the Monovalent vaccine/), PRODUCT STORAGE ERROR (On 30Dec2022, they administered a Moderna Bivalent dose to a patient, 26 hours after exposure to room temperature/ Dose administered after exposure to room temperature more than 24 hours) and NO ADVERSE EVENT (No Adverse Event) in a 24-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Dec-2022 at 10:00 AM, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Dec-2022 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (On 30Dec2022, they administered a Moderna Bivalent dose to a patient, 26 hours after exposure to room temperature/ Dose administered after exposure to room temperature more than 24 hours) and WRONG PRODUCT ADMINISTERED (administered the Bivalent as the patient's initial primary dose instead of the Monovalent vaccine/). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 30Dec2022, they administered a Moderna Bivalent dose to a patient, 26 hours after exposure to room temperature/ Dose administered after exposure to room temperature more than 24 hours) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (On 30Dec2022, they administered a Moderna Bivalent dose to a patient, 26 hours after exposure to room temperature/ Dose administered after exposure to room temperature more than 24 hours), WRONG PRODUCT ADMINISTERED (administered the Bivalent as the patient's initial primary dose instead of the Monovalent vaccine/), PRODUCT STORAGE ERROR (On 30Dec2022, they administered a Moderna Bivalent dose to a patient, 26 hours after exposure to room temperature/ Dose administered after exposure to room temperature more than 24 hours) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (On 30Dec2022, they administered a Moderna Bivalent dose to a patient, 26 hours after exposure to room temperature/ Dose administered after exposure to room temperature more than 24 hours), WRONG PRODUCT ADMINISTERED (administered the Bivalent as the patient's initial primary dose instead of the Monovalent vaccine/) and PRODUCT STORAGE ERROR (On 30Dec2022, they administered a Moderna Bivalent dose to a patient, 26 hours after exposure to room temperature/ Dose administered after exposure to room temperature more than 24 hours).    Concomitant medications were not reported.  The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that on 30-Dec-2022 at 10:00 AM, they administered a Moderna Bivalent dose to a patient, 26 hours after exposure to room temperature. During the call, they realized that they administered the Bivalent as the patient's initial primary dose instead of the Monovalent vaccine. Dose administered after exposure to room temperature more than 24 hours.  Individual vial size was 2.5 ml. On 20-Dec-2022, vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 to 25 degree celsius (C) equal 46 to 77 degree fernite (F)) 26 hours.  No treatment information was provided.