Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The date when the vials were stored in the fridge was 14Mar2023 and the dates of administration were 25Apr2023.; No adverse event; A dose of Moderna vaccine given beyond use by date. The BUD was 13 April 2023 and the vaccine was given 25 April 2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna vaccine given beyond use by date. The BUD was 13 April 2023 and the vaccine was given 25 April 2023.), PRODUCT STORAGE ERROR (The date when the vials were stored in the fridge was 14Mar2023 and the dates of administration were 25Apr2023.) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 25-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna vaccine given beyond use by date. The BUD was 13 April 2023 and the vaccine was given 25 April 2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The date when the vials were stored in the fridge was 14Mar2023 and the dates of administration were 25Apr2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna vaccine given beyond use by date. The BUD was 13 April 2023 and the vaccine was given 25 April 2023.), PRODUCT STORAGE ERROR (The date when the vials were stored in the fridge was 14Mar2023 and the dates of administration were 25Apr2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (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 dose of Moderna vaccine given beyond use by date. The BUD was 13 April 2023 and the vaccine was given 25 April 2023.) and PRODUCT STORAGE ERROR (The date when the vials were stored in the fridge was 14Mar2023 and the dates of administration were 25Apr2023).    Concomitant Medication use information was not provided by reporter.  The patient took 3rd dose of Moderna vaccine on 26-Sep-2022 by IM route having batch lot number AS7163B.  A dose of Moderna vaccine was given beyond use by date. The BUD was 13-Apr-2023 and the vaccine was given 25-Apr-2023.  The date when the vials were stored in the fridge was on 14-Mar-2023.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721275 (Linked Report). This case was linked to MOD-2023-722089 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2023: No new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721275:Master Case