Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Inadvertently administered dose of the monovalent vaccines expiration date 13-Jul-2022 Date of administration of vaccine was -26-Jul-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the monovalent vaccines expiration date 13-Jul-2022 Date of administration of vaccine was -26-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 027H21B, 046A21A and 031M20A) for COVID-19 prophylaxis.     It was not given if the patient was allergic to medications, food  and other products. It was unknown if the patient ever been diagnosed with or tested positive for covid-19. It was unknown if patient has illnesses at the time of vaccination and up to one month before. It was unknown if patient has chronic or long-standing health conditions. It was unknown if the patient was taken over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and or at the time of adverse event.    On 17-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 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the monovalent vaccines expiration date 13-Jul-2022 Date of administration of vaccine was -26-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the monovalent vaccines expiration date 13-Jul-2022 Date of administration of vaccine was -26-Jul-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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the monovalent vaccines expiration date 13-Jul-2022 Date of administration of vaccine was -26-Jul-2022).    No concomitant product reported by reporter. Patient received 2nd and 1st booster dose.  It was reported that they inadvertently administered 51 doses of the monovalent vaccines of Lot number 004M21A, expiration date as 13-Jul-2022 and was administered on 26-Jul-2022 (40 doses), 04-Aug-2022 (1 dose), 19-Aug-2022 (1 dose), 30-Sep-2022 (1 dose). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2023: Follow up has significant information which included reporter detail, patient note, suspect product route of administration and i-narrative supplement were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master case