Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion duration for vial was 3 hours and 31 minutes.; Vaccine was administered on 10-May-2022 but vaccine was expired on 16-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 10-May-2022 but vaccine was expired on 16-Apr-2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion duration for vial was 3 hours and 31 minutes.) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J21-2A, 014F21A, 023M20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 10-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 10-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 10-May-2022 but vaccine was expired on 16-Apr-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion duration for vial was 3 hours and 31 minutes.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 10-May-2022 but vaccine was expired on 16-Apr-2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion duration for vial was 3 hours and 31 minutes.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 10-May-2022 but vaccine was expired on 16-Apr-2022) to have an unknown relationship. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion duration for vial was 3 hours and 31 minutes.).    The reporter's occupation was given as clinic manager. The patient was administered 2nd booster dose on 10-May-2022. Prescriptions, over the counter medications, dietary supplements or herbal medicines being taken at the time of vaccination and or at the time of adverse event was unknown. It was reported that vials were initially frozen and then thawed out at room temperature on 10-May-2022, at the time of the excursion vials were under frozen storage, Maximum temperature was 22.1 degrees F Vials were then stored in freezer Visual inspection noting any vaccine state change was reported as no thawing Proposed desired use by Date was 16-Apr-2022 Number of vials/doses impacted were 9 vials. It was reported that expiration date on the back of the box was 16-Apr-2022 but there was another expiry date written on the lid as 07-Jul-2022, according to which vaccine was administered. No reactions were noted while in the clinic nor after vaccine. The event did not cause the patient to seek any medical care. The patient had not experienced a similar event in the past. No treatments were reported.