Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Administered dose 1 on 20-Jan-2021 and dose 2 on 23-Mar-2021; No adverse event; reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered dose 1 on 20-Jan-2021 and dose 2 on 23-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 045A21A and 042L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-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) (unknown route) dosage was changed to .25 milliliter. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered dose 1 on 20-Jan-2021 and dose 2 on 23-Mar-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered dose 1 on 20-Jan-2021 and dose 2 on 23-Mar-2021) 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 (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered dose 1 on 20-Jan-2021 and dose 2 on 23-Mar-2021).    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 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2023: Follow-up received wherein reporter details, dosage information and I narrative information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master Case