Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: No adverse event; HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022 / Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F; Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022 / Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F), PRODUCT STORAGE ERROR (Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In December 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022 / Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F) and PRODUCT STORAGE ERROR (Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022 / Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F), PRODUCT STORAGE ERROR (Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022 / Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F) and PRODUCT STORAGE ERROR (Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Lot number AS7168B. Excursion took place 15 Dec 2022 through 27 Dec 2022,  Maximum temperature reached: 46.5F,  Excursion cumulative duration was 19.3 hours. First time excursion started on 15 Dec 2022. HCP reports they gave 16 doses of the vaccines between the 15 Dec 2022 and the 21 Dec 2022 and then following that the vaccines were marked to not use. HCP says no reports of side effects have been reported to them. Concomitant medication not reported. Treatment medication not reported.