Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Patient was administered with a booster dose of Moderna COVID-19 Vaccine on 08Jun2022 with a vial that was exposed to room temperature for 27 hours; Dose administered after exposure to room temperature for 27 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with a booster dose of Moderna COVID-19 Vaccine on 08Jun2022 with a vial that was exposed to room temperature for 27 hours) and PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature for 27 hours) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A and 034F21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety disorder (No Recent change in status such as improvement or worsening was reported.) since August 2016, Gastroesophageal reflux disease (No Recent change in status such as improvement or worsening was reported) since June 2019, Benign prostatic hyperplasia (No Recent change in status such as improvement or worsening was reported) since August 2020, Penicillin allergy and Drug allergy (Allergic to codeine). Concomitant products included PARACETAMOL (ACETAMINOPHEN) for Pain, SERTRALINE, OMEPRAZOL [OMEPRAZOLE] and TAMSULOSIN for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with a booster dose of Moderna COVID-19 Vaccine on 08Jun2022 with a vial that was exposed to room temperature for 27 hours) and PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature for 27 hours). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with a booster dose of Moderna COVID-19 Vaccine on 08Jun2022 with a vial that was exposed to room temperature for 27 hours) and PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature for 27 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The height of the patient was reported as 1.75 cm. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The vial was initially stored in the refrigerator was on 6Jun2022. Date vial moved from freezer to refrigerator was on 6Jun2022. Maximum or minimum temperatures reached was reported 72 degree Fahrenheit approximately. Excursion duration was reported as 3 hours (27 hours was the total amount of time at RT). No vaccine state change was noted on visual inspection. The vial was punctured to administer 1 dose to a patient. After the administration the vial was discarded.  No adverse events were reported.  It was unknown if any treatment was given.