Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vials was initially stored in the refrigerator and  then thawed shipment received in liquid state on Oct 11 2022, vaccine was administered on 30-Nov-2022; No adverse event; Patient received doses after its beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received doses after its beyond use date), PRODUCT STORAGE ERROR (Vials was initially stored in the refrigerator and  then thawed shipment received in liquid state on Oct 11 2022, vaccine was administered on 30-Nov-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061f22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials was initially stored in the refrigerator and  then thawed shipment received in liquid state on Oct 11 2022, vaccine was administered on 30-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received doses after its beyond use date), PRODUCT STORAGE ERROR (Vials was initially stored in the refrigerator and  then thawed shipment received in liquid state on Oct 11 2022, vaccine was administered on 30-Nov-2022) 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 (Patient received doses after its beyond use date) and PRODUCT STORAGE ERROR (Vials was initially stored in the refrigerator and  then thawed shipment received in liquid state on Oct 11 2022, vaccine was administered on 30-Nov-2022).    This was the case for 3rd adult patient who received vaccine on 30-Nov-2022 out of 4 adult patients. Concomitant product use was not provided by the reporter. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vials sizes were 2.5 ml and there was total 4 vials. Vials were received in liquid state on 11-Oct-2022. Dose of administration date were as follows two doses were on 17-Nov-2022, one dose was on 30-Nov-2022 and one dose was on 22-Dec-2022. Vials did not undergo any temperature excursions. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-706651, US-MODERNATX, INC.-MOD-2023-706942, US-MODERNATX, INC.-MOD-2023-706894 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706651:Master case - 1st adult patient US-MODERNATX, INC.-MOD-2023-706942:4th adult patient US-MODERNATX, INC.-MOD-2023-706894:2nd adult