Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered, Inappropriate schedule of product administration, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Delivery of Moderna vial lot 032B21A at refrigerator temperature, Office was unware that vial was not shipped frozen, staff put vial back into freezer), EXPIRED PRODUCT ADMINISTERED (The dose was given beyond 30 days), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and ACCIDENTAL OVERDOSE (Patient administered dose 3 vaccine 0.5 ml instead of 0.25 ml) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A, 037A21B and 026A21A) for COVID-19 vaccination. The patient's past medical history included Varicose veins from 12-Dec-2012 to 17-May-2017, Wound infection (after surgery) on 26-Nov-2021, Stent placement (biliary duct) on 25-Aug-2021 and Pancreaticoduodenectomy (surgery done on 18-Nov-2021) on 23-Nov-2021. Concurrent medical conditions included Drug allergy (meperidine), Penicillin allergy, Hypothyroidism since 14-Nov-2011, Tobacco abuse since 14-Nov-2011, Gastroesophageal reflux disease since 12-Dec-2012, Anxiety since 12-Dec-2012, Depression since 12-Dec-2012, Prediabetes since 22-May-2015, Varicose veins (left lower extremity with complications) since 16-Dec-2015, Acute pancreatitis (idiopathic) since 24-Mar-2021, Transaminitis since 24-Mar-2021, Elevated liver enzymes since 24-Mar-2021, Common bile duct stone since 26-Mar-2021, Pancreatic mass since 26-Mar-2021, Obesity since 26-Mar-2021, Type 2 diabetes mellitus since 30-Jun-2021, Hyperbilirubinemia since 17-Aug-2021 and Pancreatic adenocarcinoma (on 18-NOV-2021) since 25-Aug-2021. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose was given beyond 30 days), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and ACCIDENTAL OVERDOSE (Patient administered dose 3 vaccine 0.5 ml instead of 0.25 ml). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Delivery of Moderna vial lot 032B21A at refrigerator temperature, Office was unware that vial was not shipped frozen, staff put vial back into freezer). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Delivery of Moderna vial lot 032B21A at refrigerator temperature, Office was unware that vial was not shipped frozen, staff put vial back into freezer), EXPIRED PRODUCT ADMINISTERED (The dose was given beyond 30 days), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and ACCIDENTAL OVERDOSE (Patient administered dose 3 vaccine 0.5 ml instead of 0.25 ml) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT TEMPERATURE EXCURSION ISSUE (Delivery of Moderna vial lot 032B21A at refrigerator temperature, Office was unware that vial was not shipped frozen, staff put vial back into freezer) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The dose was given beyond 30 days), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and ACCIDENTAL OVERDOSE (Patient administered dose 3 vaccine 0.5 ml instead of 0.25 ml). No concomitant medication information was provided. On 16-Jun-2021, Moderna vial (lot 032B21A) were delivered at refrigerator temperature. The reporter stated that the office was unaware that vial was not shipped frozen and staff put vial back into freezer when arrived on morning of 16-Jun-2021. Transport temperature was between 2 to 8 degrees Celsius for couple of hours. Vial was then set out on 27-Aug-2021 to thaw for one hour to room temperature. Dose of 0.5 ml then given to patient on 27-Aug-2021. Per Moderna, one re-freeze was ok, but can not be given beyond 30 days. This dose was beyond that time. Patient had no signs or symptoms of any adverse reactions to the injection given. No treatment medication were provided. Patient did not seek medical care. This case was linked to MOD-2022-539775 (Patient Link).