Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event, Product storage error
Clinical narrative: Received expired Moderna Covid-19 vaccine after 30 day beyond use date of 22 Sep 2022/ vial was initially stored in refrigerator on 22 AUG 2022 and administered on 27 SEP 2022; No Adverse event; Received expired Moderna Covid-19 vaccine after 30 day beyond use date of 22 Sep 2022/ vial was initially stored in refrigerator on 22 AUG 2022 and administered on 27 SEP 2022; Dose 1 received on 16 Aug 2022, Dose 2 received on 27 Sep 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired Moderna Covid-19 vaccine after 30 day beyond use date of 22 Sep 2022/ vial was initially stored in refrigerator on 22 AUG 2022 and administered on 27 SEP 2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 16 Aug 2022, Dose 2 received on 27 Sep 2022), PRODUCT STORAGE ERROR (Received expired Moderna Covid-19 vaccine after 30 day beyond use date of 22 Sep 2022/ vial was initially stored in refrigerator on 22 AUG 2022 and administered on 27 SEP 2022) and NO ADVERSE EVENT (No Adverse event) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9236B and AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 27-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired Moderna Covid-19 vaccine after 30 day beyond use date of 22 Sep 2022/ vial was initially stored in refrigerator on 22 AUG 2022 and administered on 27 SEP 2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 16 Aug 2022, Dose 2 received on 27 Sep 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received expired Moderna Covid-19 vaccine after 30 day beyond use date of 22 Sep 2022/ vial was initially stored in refrigerator on 22 AUG 2022 and administered on 27 SEP 2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired Moderna Covid-19 vaccine after 30 day beyond use date of 22 Sep 2022/ vial was initially stored in refrigerator on 22 AUG 2022 and administered on 27 SEP 2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 16 Aug 2022, Dose 2 received on 27 Sep 2022), PRODUCT STORAGE ERROR (Received expired Moderna Covid-19 vaccine after 30 day beyond use date of 22 Sep 2022/ vial was initially stored in refrigerator on 22 AUG 2022 and administered on 27 SEP 2022) 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 (Received expired Moderna Covid-19 vaccine after 30 day beyond use date of 22 Sep 2022/ vial was initially stored in refrigerator on 22 AUG 2022 and administered on 27 SEP 2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 16 Aug 2022, Dose 2 received on 27 Sep 2022) and PRODUCT STORAGE ERROR (Received expired Moderna Covid-19 vaccine after 30 day beyond use date of 22 Sep 2022/ vial was initially stored in refrigerator on 22 AUG 2022 and administered on 27 SEP 2022).    Concomitant medication information was not provided by the reporter.  The vial was initially stored in the refrigerator on 22-Aug-2022. Patient received expired Moderna COVID-19 vaccine after 30 day. Beyond use date was reported as 22-Sep-2022. Vaccine was in unbroken cartons and vial size was 2.5ml. The vial did not undergo any temperature excursions.  Treatment information was not provided by the reporter.   This case was linked to MOD22-025031 (Linked Report).; Sender's Comments:  MOD22-025031: