Age: 55.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Moderna Bivalent vaccine (6yrs and older) that was left at room temp for less than 48 hours, but more than 24 hours; no adverse event; Moderna Bivalent vaccine (6yrs and older) that was left at room temp for less than 48 hours, but more than 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine (6yrs and older) that was left at room temp for less than 48 hours, but more than 24 hours), PRODUCT STORAGE ERROR (Moderna Bivalent vaccine (6yrs and older) that was left at room temp for less than 48 hours, but more than 24 hours) and NO ADVERSE EVENT (no adverse event) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     It was reported that patient had no allergies.  Concurrent medical conditions included MS.    On 01-Mar-2023 at 2:15 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 01-Mar-2023 at 2:15 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine (6yrs and older) that was left at room temp for less than 48 hours, but more than 24 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Bivalent vaccine (6yrs and older) that was left at room temp for less than 48 hours, but more than 24 hours) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine (6yrs and older) that was left at room temp for less than 48 hours, but more than 24 hours), PRODUCT STORAGE ERROR (Moderna Bivalent vaccine (6yrs and older) that was left at room temp for less than 48 hours, but more than 24 hours) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine (6yrs and older) that was left at room temp for less than 48 hours, but more than 24 hours) and PRODUCT STORAGE ERROR (Moderna Bivalent vaccine (6yrs and older) that was left at room temp for less than 48 hours, but more than 24 hours).    Concomitant medications were not reported.  Patient did not experienced a similar event in the past.  The pharmacist was inquiring about the potential side effects and stability of the Moderna Bivalent vaccine (6yrs and older) that was left at room temp for less than 48 hours, but more than 24 hours and was also administered it after 12 hours post puncture to 2 adult female patients.   Moderna bivalent booster was taken out of fridge on 28-Feb-2023 and was kept at room temperature until the next day. Patient was given vaccine from same vial on 01-Mar-2023 at about 02:15pm (i.e. vaccine was not kept at appropriate condition and was administered). The vaccine administrator did not know vial was punctured the day before. Patient was informed of the above and has not reported any event.   This case contains information for the 2nd female described by the reporter.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713812 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Mar-2023: Follow-up received wherein reporter details, patient details, medical history, dose details, event start date and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713812:Female 1