Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 23-Feb-2022; No adverse event; Received Expired Monovalent vaccine after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 23-Feb-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 23-Feb-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 23-Feb-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 23-Feb-2022).    Concomitant product use was not provided by the reporter. Vial sizes were reported as 2.5 mL Bivalent and 5.5 ml was in red cap. Vaccine thawed date was mentioned as 12-Feb-2022. Monovalent lot number 025L21B which was shipped on 13-JAN-2022 and was thawed in a cooler while being transported. Vials did not undergo any temperature excursions. Since reporter did not notice the vaccine was expired, some of these patients received another dose after the expired dose was given, within recommended time. Reporter did not have any patient identifier at the time of reporting. Treatment information was not provided. This case was for seventh adult patient from seven adult patients case who were received Monovalent shots on 23-FEB-2022.   This case was linked to US-MODERNATX, INC.-MOD-2022-682174, US-MODERNATX, INC.-MOD-2022-682176, US-MODERNATX, INC.-MOD-2022-682100 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2022: Live Significant FU : Reporter added , Narrative updated (Clarification response received).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682174:Monovalent (Same reporter) US-MODERNATX, INC.-MOD-2022-682176:Monovalent (Same reporter) US-MODERNATX, INC.-MOD-2022-682100:Monovalent (Same reporter; Adult patient 7 from 7 Adult patients Monovalent shots on 23FEB2022)