Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patient received Moderna Covid-19 vaccine that was opened on 15AUG2022 and left at room temperature for 25 hours; No adverse event; The Moderna Covid-19 vaccine vial had also been punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The Moderna Covid-19 vaccine vial had also been punctured more than 12 hours ago), PRODUCT STORAGE ERROR (Patient received Moderna Covid-19 vaccine that was opened on 15AUG2022 and left at room temperature for 25 hours) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 055A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2022 at 3:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The Moderna Covid-19 vaccine vial had also been punctured more than 12 hours ago). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received Moderna Covid-19 vaccine that was opened on 15AUG2022 and left at room temperature for 25 hours) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The Moderna Covid-19 vaccine vial had also been punctured more than 12 hours ago), PRODUCT STORAGE ERROR (Patient received Moderna Covid-19 vaccine that was opened on 15AUG2022 and left at room temperature for 25 hours) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The Moderna Covid-19 vaccine vial had also been punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (Patient received Moderna Covid-19 vaccine that was opened on 15AUG2022 and left at room temperature for 25 hours).    This case contains information for the first patient (in the family of 3) who received the vaccine (first administration) on 16Aug2022 at 3:00PM as described by the reporter. No concomitant medications information was reported. Lot number, expiration date, and arm of administration of primary doses and first booster dose were not known. The vial was initially stored in the refrigerator on 19JUL2022 It was reported that vial of Moderna Covid-19 vaccine was taken out of the refrigerator on 15-AUG-2022 at 2:15PM. The vial was first punctured at 2:30PM on 15AUG2022. Patient received second Moderna Booster Covid-19 vaccine that was opened on 15AUG2022 and left at room temperature for 25 hours. The Moderna Covid-19 vaccine vial had also been punctured more than 12 hours ago. The vial did not undergo any temperature excursions. The expiration date was not known. No other adverse reactions were observed. No treatment medications were provided.