Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Expired product administered, Interchange of vaccine products, No adverse event, Product storage error
Clinical narrative: Vial was fist punctured on 29-Aug-2022 and stored in refrigerator post puncture for more than 12 hours; No adverse event; Patient received vaccine as first dose and Moderna vaccine as second dose; Patient received vaccine as first dose and Moderna vaccine as second dose; patient received Moderna Covid-19 6 months through 5 years of age vaccine that had been punctured more than 12 hours ago.; This spontaneous case was reported by a physician and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received vaccine as first dose and Moderna vaccine as second dose), COVID-19 IMMUNISATION (Patient received vaccine as first dose and Moderna vaccine as second dose), EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 6 months through 5 years of age vaccine that had been punctured more than 12 hours ago.), PRODUCT STORAGE ERROR (Vial was fist punctured on 29-Aug-2022 and stored in refrigerator post puncture for more than 12 hours) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: COVID-19 vaccine. Past adverse reactions to the above products included No adverse event with COVID-19 vaccine.    On 30-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received vaccine as first dose and Moderna vaccine as second dose), COVID-19 IMMUNISATION (Patient received vaccine as first dose and Moderna vaccine as second dose) and EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 6 months through 5 years of age vaccine that had been punctured more than 12 hours ago.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was fist punctured on 29-Aug-2022 and stored in refrigerator post puncture for more than 12 hours) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received vaccine as first dose and Moderna vaccine as second dose), COVID-19 IMMUNISATION (Patient received vaccine as first dose and Moderna vaccine as second dose), EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 6 months through 5 years of age vaccine that had been punctured more than 12 hours ago.), PRODUCT STORAGE ERROR (Vial was fist punctured on 29-Aug-2022 and stored in refrigerator post puncture for more than 12 hours) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (Patient received vaccine as first dose and Moderna vaccine as second dose), COVID-19 IMMUNISATION (Patient received vaccine as first dose and Moderna vaccine as second dose), EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 6 months through 5 years of age vaccine that had been punctured more than 12 hours ago.) and PRODUCT STORAGE ERROR (Vial was fist punctured on 29-Aug-2022 and stored in refrigerator post puncture for more than 12 hours).    No concomitant product reported by reporter.  The patient received the vaccine for her first COVID-19 vaccine. This dose was deemed as not valid.  Then patient received Moderna Covid-19 vaccine on 30-AUG-2022.  The vial was initially stored in refrigerator on 03-Aug-2022 and was first punctured on 29-Aug-2022 and was administered on 30-Aug-2022 exceeding 12 hours time limit.  Vial was stored in refrigerator post puncture. Vial did not undergone any temperature excursion issue. Total amount of time the vial was exposed to room temperature range (8 to 25 degree Celsius or 46 to 77 degree Fahrenheit) was less than 20 minutes.  No adverse events were observed.  No treatment medication reported by the reporter.