Age: 90.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Excursion took place 15Dec2022 through 27Dec2022/ Maximum temperature reached was 46.5F; No adverse event; Maximum temperature reached 46.5F/ Excursion cumulative duration 19.3 hours/16 doses of the vaccines given between the 15Dec2022 and the 21Dec2022 and then following that the vaccines were marked to not use; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022/ Maximum temperature reached was 46.5F), POOR QUALITY PRODUCT ADMINISTERED (Maximum temperature reached 46.5F/ Excursion cumulative duration 19.3 hours/16 doses of the vaccines given between the 15Dec2022 and the 21Dec2022 and then following that the vaccines were marked to not use) and NO ADVERSE EVENT (No adverse event) in a 90-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 20-Dec-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 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 (Maximum temperature reached 46.5F/ Excursion cumulative duration 19.3 hours/16 doses of the vaccines given between the 15Dec2022 and the 21Dec2022 and then following that the vaccines were marked to not use). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022/ Maximum temperature reached was 46.5F) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022/ Maximum temperature reached was 46.5F), POOR QUALITY PRODUCT ADMINISTERED (Maximum temperature reached 46.5F/ Excursion cumulative duration 19.3 hours/16 doses of the vaccines given between the 15Dec2022 and the 21Dec2022 and then following that the vaccines were marked to not 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)) (Intramuscular), 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 15Dec2022 through 27Dec2022/ Maximum temperature reached was 46.5F) and POOR QUALITY PRODUCT ADMINISTERED (Maximum temperature reached 46.5F/ Excursion cumulative duration 19.3 hours/16 doses of the vaccines given between the 15Dec2022 and the 21Dec2022 and then following that the vaccines were marked to not use).    Concomitant medication was not reported. It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. First time excursion started on 15Dec2022. No reports of side effects have been reported. All patients received vaccines at pharmacy. Treatment drug was not reported.