Age: 31.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine was first drawn from the vial on 27-Apr-2023 at 09:00 am and was administered on 28-Apr-2023 at 09:15 am; No adverse event; HCP reports that they administered a dose of the bivalent vaccine from a prefilled syringe exposed to room temperature for more than 24 hours.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP reports that they administered a dose of the bivalent vaccine from a prefilled syringe exposed to room temperature for more than 24 hours.), PRODUCT STORAGE ERROR (The vaccine was first drawn from the vial on 27-Apr-2023 at 09:00 am and was administered on 28-Apr-2023 at 09:15 am) and NO ADVERSE EVENT (No adverse event) in a 31-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     Patient had no medical history or conditions, allergy, concomitant diseases or any risk factor. It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, lot number - 048C21A) on 13-Jul-2021, Moderna COVID-19 Vaccine (Dose 2 and lot number 040C21A) on 11-Aug-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 28-Apr-2023 at 9:15 AM, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Apr-2023 at 9:15 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 (HCP reports that they administered a dose of the bivalent vaccine from a prefilled syringe exposed to room temperature for more than 24 hours.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was first drawn from the vial on 27-Apr-2023 at 09:00 am and was administered on 28-Apr-2023 at 09:15 am) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP reports that they administered a dose of the bivalent vaccine from a prefilled syringe exposed to room temperature for more than 24 hours.), PRODUCT STORAGE ERROR (The vaccine was first drawn from the vial on 27-Apr-2023 at 09:00 am and was administered on 28-Apr-2023 at 09:15 am) 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 (HCP reports that they administered a dose of the bivalent vaccine from a prefilled syringe exposed to room temperature for more than 24 hours.) and PRODUCT STORAGE ERROR (The vaccine was first drawn from the vial on 27-Apr-2023 at 09:00 am and was administered on 28-Apr-2023 at 09:15 am).    Concomitant drugs were not reported.  It was reported that the vial was not exposed to temperature excursion and patient had not reported any AE so far.  Treatment medications were not provided.