Age: 31.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, 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; 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; 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), POOR QUALITY PRODUCT ADMINISTERED (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 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. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-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. On 15-Dec-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 POOR QUALITY PRODUCT ADMINISTERED (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). 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), POOR QUALITY PRODUCT ADMINISTERED (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 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 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 POOR QUALITY PRODUCT ADMINISTERED (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).    No concomitant drug was reported. It was reported that excursion cumulative duration was 19.3 hours. First time excursion started on 15-Dec-2022. HCP reported that 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 said no reports of side effects have been reported to them.  No treatment drug was reported.