Age: 32.0
Sex: F
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; Patient received dose of Moderna Covid-19 vaccine from a vial that had been punctured more than 12 hours ago.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of Moderna Covid-19 vaccine from a vial that had 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 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 055A22A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first 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 (Patient received dose of Moderna Covid-19 vaccine from a vial that had 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 (Patient received dose of Moderna Covid-19 vaccine from a vial that had 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 (Patient received dose of Moderna Covid-19 vaccine from a vial that had 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).    No concomitant medications were reported.  On 19-Jul-2022, the vial was initially stored in the refrigerator. On 15-Aug-2022 at 02.15 PM, a vial of Moderna COVID-19 vaccine was taken out of the refrigerator and at 02.30 PM, the vial was punctured for the first time. Post punctured, the vial was stored at room temperature and the total amount of time the vial was exposed to room temperature was 25 hours. Reportedly, the vial did not undergo any temperature excursions.   Later, the dose were administered from vial to the 3 related family member on 16-Aug-2022 at 3:00PM (first administration), at 3:10PM (second administration) and at 3:15 PM (Third administration).  The patient received second booster dose on 16-Aug-2022 that was opened on 15-Aug-2022 and left at room temperature for 25 hours. The Moderna Covid-19 vaccine vial had also been punctured more than 12 hours ago. No other adverse reactions were observed.  No treatment information was provided by the reporter.