Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was expired on 20-May-2022 but the vial was initially stored in the refrigerator was on 07-JUN-2022; No adverse Event; patient received Moderna Covid-19 vaccine that was expired and past the Manufacturers expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine that was expired and past the Manufacturers expiration date), PRODUCT STORAGE ERROR (The vial was expired on 20-May-2022 but the vial was initially stored in the refrigerator was on 07-JUN-2022) and NO ADVERSE EVENT (No adverse Event) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     It was unknown, if the patient was ever tested or diagnosed with COVID. It was unknown if the history was related to mentioned event and both Acute and Chronic illnesses at the time of vaccination. It was unknown that patient had chronic or long-standing health conditions. It was unknown if other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. It was reported that the patient had not experienced any similar event in the past.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine that was expired and past the Manufacturers expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was expired on 20-May-2022 but the vial was initially stored in the refrigerator was on 07-JUN-2022) and NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine that was expired and past the Manufacturers expiration date), PRODUCT STORAGE ERROR (The vial was expired on 20-May-2022 but the vial was initially stored in the refrigerator was on 07-JUN-2022) and NO ADVERSE EVENT (No adverse Event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine that was expired and past the Manufacturers expiration date) and PRODUCT STORAGE ERROR (The vial was expired on 20-May-2022 but the vial was initially stored in the refrigerator was on 07-JUN-2022).    No concomitant medication were reported.  It was unknown that patient had prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination or at the time of adverse event.It was unknown if the adverse event caused the patient to seek medical care (office visit, Urgent care, ER, hospitalized) and the symptoms were improved or worsened.  It was reported that reporter thought that she saw that the expiration date is 20-JUN-2022 when she looked this up before however she had nothing in writing or printed to confirm the expiration date of 20-JUN-2022.The vial had not undergone any temperature excursion.The patient had not experience any adverse events.It was also unknown, that if patient took any medical care.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2022: Follow up received contains significant information, suspect vaccine dose details were added and expiry date of suspect vaccine was updated. On 02-Sep-2022: Follow up received contains non significant information.