Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: administered 1 dose this morning 29Dec2022 after the excursion; Product Storage Error; No Adverse Event; administered 1 dose this morning 29Dec2022 after the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 1 dose this morning 29Dec2022 after the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (administered 1 dose this morning 29Dec2022 after the excursion), PRODUCT STORAGE ERROR (Product Storage Error) and NO ADVERSE EVENT (No Adverse Event) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE. Past adverse reactions to the above products included No adverse reaction with COVID-19 VACCINE.    On 29-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 1 dose this morning 29Dec2022 after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered 1 dose this morning 29Dec2022 after the excursion), PRODUCT STORAGE ERROR (Product Storage Error) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 1 dose this morning 29Dec2022 after the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (administered 1 dose this morning 29Dec2022 after the excursion), PRODUCT STORAGE ERROR (Product Storage Error) 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 (administered 1 dose this morning 29Dec2022 after the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (administered 1 dose this morning 29Dec2022 after the excursion) and PRODUCT STORAGE ERROR (Product Storage Error).    No concomitants products reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19. The patient had previous 4 doses of COVID-19 vaccination. The nurse states there was an incident where the fridge was left open from 3:30 PM yesterday 28 Dec 2022 to 8:30 AM this morning 29 Dec 2022. They had 25 doses of Moderna bivalent with lot number 043H22A. They administered 1 dose this morning 29Dec2022 after the excursion around 11 AM. They were being recommended to waste what was not given, but they were wondering if the dose given was valid. The nurse preferred to be contacted by email. That was the patient's 5th dose of Moderna, but his first bivalent booster. No adverse event was reported from the patient.  No treatment products reported.