Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Moderna vaccine expired on 20-May-2022 and was stored in refrigerator on 07-Jun-2022; No adverse event; The patient received Moderna COVID-19 vaccine 19 days after the expiration date and also past the manufacturers expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received Moderna COVID-19 vaccine 19 days after the expiration date and also past the manufacturers expiration date), PRODUCT STORAGE ERROR (Moderna vaccine expired on 20-May-2022 and was stored in refrigerator on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-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 (The patient received Moderna COVID-19 vaccine 19 days after the expiration date and also past the manufacturers expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine expired on 20-May-2022 and was stored in refrigerator on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received Moderna COVID-19 vaccine 19 days after the expiration date and also past the manufacturers expiration date), PRODUCT STORAGE ERROR (Moderna vaccine expired on 20-May-2022 and was stored in refrigerator on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 (The patient received Moderna COVID-19 vaccine 19 days after the expiration date and also past the manufacturers expiration date) and PRODUCT STORAGE ERROR (Moderna vaccine expired on 20-May-2022 and was stored in refrigerator on 07-Jun-2022).    No concomitant medications were reported.  It was unknown if the patient ever been diagnosed with or tested positive for COVID-19. It was unknown if the patient had acute illness at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions. It was unknown if the 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.  Moderna booster doses were given to 27 patients 19 days after expiration date of 20-May-2022.  On 07-Jun-2022, vial was initially stored in the refrigerator.  Vial did not undergo any temperature excursions.  No adverse event was reported.  It was unknown if patient had experienced similar event in the past or if the event caused the patient to seek medical care.  No treatment medication was reported.      Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2022: Follow up received contains significant information: Suspect vaccine details were added, and narrative updated. On 02-Sep-2022: Follow up received contains non-significant information: Narrative was updated.