Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours.HCP reported that patient received the vaccines on 20-Dec-2022 and then following that the vaccines were marked not to use; excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022), POOR QUALITY PRODUCT ADMINISTERED (Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours.HCP reported that patient received the vaccines on 20-Dec-2022 and then following that the vaccines were marked not to use) and NO ADVERSE EVENT (No adverse event) in an 89-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 20-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 (excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022). On 20-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours.HCP reported that patient received the vaccines on 20-Dec-2022 and then following that the vaccines were marked not to use). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022), POOR QUALITY PRODUCT ADMINISTERED (Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours.HCP reported that patient received the vaccines on 20-Dec-2022 and then following that the vaccines were marked not to use) 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 (excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022) and POOR QUALITY PRODUCT ADMINISTERED (Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours.HCP reported that patient received the vaccines on 20-Dec-2022 and then following that the vaccines were marked not to use).    No concomitant medication was reported.    It was reported that first time excursion started on 15-Dec-2022. It was unknown that patient received any other vaccine in the 4 weeks prior to COVID-19 vaccine and also no reports of side effects had been reported to them.All patients received vaccines at pharmacy No treatment information was reported.