Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: No adverse event; 3 infant patients received doses after the beyond use date; vials WERE ALSO AFFECTED BY A TEMPERATURE EXCURSION; vials WERE ALSO AFFECTED BY A TEMPERATURE EXCURSION; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 infant patients received doses after the beyond use date), PRODUCT TEMPERATURE EXCURSION ISSUE (vials WERE ALSO AFFECTED BY A TEMPERATURE EXCURSION), PRODUCT STORAGE ERROR (vials WERE ALSO AFFECTED BY A TEMPERATURE EXCURSION) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 infant patients received doses after the beyond use date), PRODUCT TEMPERATURE EXCURSION ISSUE (vials WERE ALSO AFFECTED BY A TEMPERATURE EXCURSION) and PRODUCT STORAGE ERROR (vials WERE ALSO AFFECTED BY A TEMPERATURE EXCURSION). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 infant patients received doses after the beyond use date), PRODUCT TEMPERATURE EXCURSION ISSUE (vials WERE ALSO AFFECTED BY A TEMPERATURE EXCURSION), PRODUCT STORAGE ERROR (vials WERE ALSO AFFECTED BY A TEMPERATURE EXCURSION) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (3 infant patients received doses after the beyond use date), PRODUCT TEMPERATURE EXCURSION ISSUE (vials WERE ALSO AFFECTED BY A TEMPERATURE EXCURSION) and PRODUCT STORAGE ERROR (vials WERE ALSO AFFECTED BY A TEMPERATURE EXCURSION).    It was reported that 3 infant patients received doses after the beyond use date  lot- AR9236B Moderna COVID19 vaccine monovalent, 6 months to 5 years, which vials were also affected by a temperature excursion. Compliance inspector wanted to report and asked for an assessment in regards to pediatric patients (6 months to 5 years old) receiving doses of the Monovalent Moderna COVID19 vaccine after the beyond use date. HCP wanted to know if the patients should be revaccinated or not. Dose were administered after 30-day use by date. Individual vials or unbroken cartons were stored in the box 4. Vial size was unknown to the reporter. The vial was initially stored in the refrigerator on 13-Sep-2022. The vial underwent temperature excursions were monovalent, uring excursion vials were stored in refrigerated storage 3. Maximum or minimum temperatures reached was 6-degree Fahrenheit and 45.3 degree Fahrenheit. Excursion duration was 2 hours and 21 minutes 8. Vails were maintained in fridge. No concomitant medication were reported. No treatment medication were reported.