Age: 107.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: First dose :10/28/2021, second dose :2/14/2022, first boster dose: 2/14/2022; No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose :10/28/2021, second dose :2/14/2022, first boster dose: 2/14/2022) and NO ADVERSE EVENT (No adverse event) in a 107-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 069H21A and 001A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2022, 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 milliliter. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose :10/28/2021, second dose :2/14/2022, first boster dose: 2/14/2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose :10/28/2021, second dose :2/14/2022, first boster dose: 2/14/2022) 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 (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose :10/28/2021, second dose :2/14/2022, first boster dose: 2/14/2022).    No concomitant medicine were reported.  It was unknown patient was ever been diagnosed with or tested positive for COVID-19. It was unknown if patient had acute illness at the time of vaccination and up to one month before and about chronic or long standing health conditions. It was unknow if patient took prescription, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination and/or at the time of the adverse event.  It was reported that patient was inadvertently administered doses of the monovalent vaccines for which expiration date was 13-Jul-2022.  No treatment medicine were 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 received wherein reporter details, route of administration, dosage information, vaccination site and I narrative information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:master case