Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 11-Oct-2022 and vaccines were admistered on 16Nov2022, 5 patients, 30Nov2022, 3 patients (two different vials); No adverse event; Patients received bivalent dose after its beyond use date; This spontaneous case was reported by a physician assistant and describes the occurrence of PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Oct-2022 and vaccines were admistered on 16Nov2022, 5 patients, 30Nov2022, 3 patients (two different vials)), EXPIRED PRODUCT ADMINISTERED (Patients received bivalent dose after its beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In November 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In November 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received bivalent dose after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Oct-2022 and vaccines were admistered on 16Nov2022, 5 patients, 30Nov2022, 3 patients (two different vials)) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Oct-2022 and vaccines were admistered on 16Nov2022, 5 patients, 30Nov2022, 3 patients (two different vials)), EXPIRED PRODUCT ADMINISTERED (Patients received bivalent dose after its beyond use date) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Oct-2022 and vaccines were admistered on 16Nov2022, 5 patients, 30Nov2022, 3 patients (two different vials)) and EXPIRED PRODUCT ADMINISTERED (Patients received bivalent dose after its beyond use date).    No concomitant medication information was provided.  Dose administered after 30-day Use By Date or after manufacturer date of expiry   Vial size was reported as 2.5ml  The vial was initially stored in the refrigerator on 11-Oct-2022.  Date(s) of administration of vaccine on 16-Nov-2022 for 5 patients and on 30-Nov-2022 for 3 patients in two different vials.  The vial did not undergo any temperature excursions.  No treatment medication were provided.  This case contains information for the 5th adult patient out of 8 adults patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-680810, US-MODERNATX, INC.-MOD-2022-680811, US-MODERNATX, INC.-MOD-2022-680808 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-680810:Samer Reporter US-MODERNATX, INC.-MOD-2022-680811:Samer Reporter US-MODERNATX, INC.-MOD-2022-680808:Samer Reporter