Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Expired product administered, Product storage error, SARS-CoV-2 test
Clinical narrative: COVID-19; Vaccine had been expired for 2 weeks, stored in fridge on 17-May-2022; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19), EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Vaccine had been expired for 2 weeks, stored in fridge on 17-May-2022) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 067F21A, 030A21A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced COVID-19 (COVID-19) and PRODUCT STORAGE ERROR (Vaccine had been expired for 2 weeks, stored in fridge on 17-May-2022). At the time of the report, COVID-19 (COVID-19), EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Vaccine had been expired for 2 weeks, stored in fridge on 17-May-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. The patient does not have any known drug allergies. The caller was a health care professional who stated that they administered the Moderna COVID-19 vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks. The caller explained that since the expiration date was not written on the vial they had not noticed it had already expired. Date the vial was initially stored in the refrigerator: 17-May-2022. The vial did not undergo any temperature excursions. Number of doses/vials: 26 doses. Treatment information was not provided. Company comment- This is a spontaneous case concerning a 67-year-old patient of unknown gender with no medical history reported who experienced the unexpected AESI COVID-19. Four doses of mRNA-1273 vaccine were administered. Temporal association cannot be assessed due to lack of information on onset date of the event.  Patient tested positive for COVID-19 on an unknown date. Additionally, expired product administered, and product storage error were also reported. It was reported that they administered the Moderna COVID-19 vaccine and then found out that the vaccine had been expired for 2 weeks. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 67-year-old patient of unknown gender with no medical history reported who experienced the unexpected AESI COVID-19. Four doses of mRNA-1273 vaccine were administered. Temporal association cannot be assessed due to lack of information on onset date of the event.  Patient tested positive for COVID-19 on an unknown date. Additionally, expired product administered, and product storage error were also reported. It was reported that they administered the Moderna COVID-19 vaccine and then found out that the vaccine had been expired for 2 weeks. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.