Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; HCP reported that patient received the vaccine on 19-Dec-2022 and then following that the vaccine was marked not to use.; Excursion took place on 15-Dec-2022 through 27-Dec-2022 maximum temperature reached was 46.5 F and excursion cumulative duration was19.3 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place on 15-Dec-2022 through 27-Dec-2022 maximum temperature reached was 46.5 F and excursion cumulative duration was19.3 hours), POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccine on 19-Dec-2022 and then following that the vaccine was marked not to use.) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female 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 19-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 (Excursion took place on 15-Dec-2022 through 27-Dec-2022 maximum temperature reached was 46.5 F and excursion cumulative duration was19.3 hours). On 19-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 (HCP reported that patient received the vaccine on 19-Dec-2022 and then following that the vaccine was 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 took place on 15-Dec-2022 through 27-Dec-2022 maximum temperature reached was 46.5 F and excursion cumulative duration was19.3 hours), POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccine on 19-Dec-2022 and then following that the vaccine was 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 took place on 15-Dec-2022 through 27-Dec-2022 maximum temperature reached was 46.5 F and excursion cumulative duration was19.3 hours) and POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccine on 19-Dec-2022 and then following that the vaccine was marked not to use.).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was unknown that patient received any other vaccine in the 4 weeks prior to COVID-19 vaccine. It was reported that first time excursion started on 15-Dec-2022 and HCP reported that they had given 16 doses of the vaccines between the 15-Dec-2022 and the 21-Dec-2022 and then following that the vaccines were marked not to use and also no reports of side effects had been reported to them. No treatment information was provided.