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). On 13-May-2022, NO ADVERSE EVENT (No adverse event) outcome was unknown. At the time of the report, 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) 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).    No concomitant medication information was provided. That case was for third adult patient from seven adult patients' case who were received Monovalent shots on 23-FEB-2022. Vial sizes were reported as 2.5 mL or 5.5 mL and 5.5 ml was in red cap. 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. No treatment medication were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-682174, US-MODERNATX, INC.-MOD-2022-682176, US-MODERNATX, INC.-MOD-2022-682100 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2022: Follow up Received: Event product storage error added, start date of event expired vaccine added. Reporter added, Narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682176:Monovalent (Same reporter) US-MODERNATX, INC.-MOD-2022-682174:Monovalent (Same reporter) US-MODERNATX, INC.-MOD-2022-682100:Monovalent (Same reporter; Adult patient 3 from 7 Adult patients Monovalent shots on 23FEB2022)