Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: HCP stated a patient was vaccinated with Moderna COVID-19 Vaccine Bivalent after the vial spend more than 24 hours at room temperature. The vaccine was exposed to room temperature since 16Dec2022 at 4:30 PM to 19Dec2022 at 9 AM.; HCP stated a patient was vaccinated with Moderna COVID-19 Vaccine Bivalent after the vial spend more than 24 hours at room temperature. The vaccine was exposed to room temperature since 16Dec2022 at 4:30 PM to 19Dec2022 at 9 AM.; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated a patient was vaccinated with Moderna COVID-19 Vaccine Bivalent after the vial spend more than 24 hours at room temperature. The vaccine was exposed to room temperature since 16Dec2022 at 4:30 PM to 19Dec2022 at 9 AM.), PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated a patient was vaccinated with Moderna COVID-19 Vaccine Bivalent after the vial spend more than 24 hours at room temperature. The vaccine was exposed to room temperature since 16Dec2022 at 4:30 PM to 19Dec2022 at 9 AM.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an 87-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Second dose) on 25-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (First booster (Third dose)) on 06-Dec-2021 and PFIZER BIONTECH COVID-19 VACCINE (First dose) until 04-Mar-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Prostate cancer, Chronic kidney disease stage 3 and Coronary artery disease.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated a patient was vaccinated with Moderna COVID-19 Vaccine Bivalent after the vial spend more than 24 hours at room temperature. The vaccine was exposed to room temperature since 16Dec2022 at 4:30 PM to 19Dec2022 at 9 AM.), PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated a patient was vaccinated with Moderna COVID-19 Vaccine Bivalent after the vial spend more than 24 hours at room temperature. The vaccine was exposed to room temperature since 16Dec2022 at 4:30 PM to 19Dec2022 at 9 AM.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated a patient was vaccinated with Moderna COVID-19 Vaccine Bivalent after the vial spend more than 24 hours at room temperature. The vaccine was exposed to room temperature since 16Dec2022 at 4:30 PM to 19Dec2022 at 9 AM.), PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated a patient was vaccinated with Moderna COVID-19 Vaccine Bivalent after the vial spend more than 24 hours at room temperature. The vaccine was exposed to room temperature since 16Dec2022 at 4:30 PM to 19Dec2022 at 9 AM.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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 EXPIRED PRODUCT ADMINISTERED (HCP stated a patient was vaccinated with Moderna COVID-19 Vaccine Bivalent after the vial spend more than 24 hours at room temperature. The vaccine was exposed to room temperature since 16Dec2022 at 4:30 PM to 19Dec2022 at 9 AM.), PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated a patient was vaccinated with Moderna COVID-19 Vaccine Bivalent after the vial spend more than 24 hours at room temperature. The vaccine was exposed to room temperature since 16Dec2022 at 4:30 PM to 19Dec2022 at 9 AM.) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant medications details were reported.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned no AEs were reported.   Moderna was authorized to communicate with the vaccine recipient's primary healthcare professional regarding notification.  No treatment medications details were reported.