Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: 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; First dose given on 11/01/2021 and 2nd dose given on 28/02/202.; 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 given on 11/01/2021 and 2nd dose given on 28/02/202.) and NO ADVERSE EVENT (No adverse event) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 025L20A and 030L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-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) (Intramuscular) dosage was changed to .25 milliliter. On 28-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose given on 11/01/2021 and 2nd dose given on 28/02/202.). 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 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 given on 11/01/2021 and 2nd dose given on 28/02/202.) 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 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 given on 11/01/2021 and 2nd dose given on 28/02/202.).    Concomitant Medication use information was not provided by reporter.  A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines. They want to know what their next step would be for these patients. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose).   It was unknown that the patient ever been diagnosed with/tested positive for COVID-19  It was unknown that the patient had acute illness at the time of vaccination and up to one month before.  It was unknown that the patient had any chronic or long-standing health conditions.  It was unknown that the patient was prescribed OTC medications, dietary supplements or herbal remedies being taken at the time of vaccination and/or at the time of adverse event.  Treatment Medication use information was not provided by reporter.   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 that contains significant information includes added reporter details, added suspect product of the 4th dose route of administration and location of vaccination and updated narrative information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Matser case