Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Expired product administered, SARS-CoV-2 test
Clinical narrative: Positive for Covid-19; Received the Moderna Covid 19 vaccine after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Positive for Covid-19) and EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after manufacturer date of expiry) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 017F21A, 026L20A and 026L20A) for COVID-19 vaccination.     Patient had no known drug allergies.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after manufacturer date of expiry). On an unknown date, the patient experienced COVID-19 (Positive for Covid-19). At the time of the report, COVID-19 (Positive for Covid-19) and EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after manufacturer date of expiry) 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 Covid-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication was reported.  Number of doses/vials: 26 doses some were primary doses and some boosters. The vial was stored in the refrigerator on 17-May-2022. The vial did not undergo any temperature excursion. The patient had not reported side effects.  No information on treatment medications was reported.  Company Comment: This is a Spontaneus case concerning  69-year-old patient of an unknown gender with no previous relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 on an unknown date and the patient received the fourth dose of mRNA-1273 for COVID-19 vaccination. Expired product administered was also reported with the same dose. Clinical course with treatment details were not provided. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender's Comments: This is a Spontaneus case concerning  69-year-old patient of an unknown gender with no previous relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 on an unknown date and the patient received the fourth dose of mRNA-1273 for COVID-19 vaccination. Expired product administered was also reported with the same dose. Clinical course with treatment details were not provided. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.