Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: They had a excursion on 04-Jun-2022; Vial was expired on 13-Jul-2022 and refrigerated on 17-Jul and 18-Jul-2022; Vaccine was expired on 13-Jul-2022 and administered on 18-Jul-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-Jul-2022 and administered on 18-Jul-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (They had a excursion on 04-Jun-2022) and PRODUCT STORAGE ERROR (Vial was expired on 13-Jul-2022 and refrigerated on 17-Jul and 18-Jul-2022) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-Jul-2022 and administered on 18-Jul-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (They had a excursion on 04-Jun-2022) and PRODUCT STORAGE ERROR (Vial was expired on 13-Jul-2022 and refrigerated on 17-Jul and 18-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-Jul-2022 and administered on 18-Jul-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (They had a excursion on 04-Jun-2022) and PRODUCT STORAGE ERROR (Vial was expired on 13-Jul-2022 and refrigerated on 17-Jul and 18-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no known allergies. Acute or Chronic illness at the time of vaccination was reported as none.  No concomitant medication was reported by reporter.  Patient received booster dose on 18-Jul-2022.  During time of excursion (5.8 degree F maximum) for 15min, vials were in frozen storage. 3 affected vials were stored in refrigerator on 17-Jul-2022 and 18-Jul-2022. Currently those vials were wasted and 1 vial was stored. Vaccines did not have a change in state and were still frozen. The impacted vials were not punctured and never had any previous excursions.  It was unknown whether patient ever had COVID positive test or diagnosis.  It was unknown whether other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose).  It was unknown whether patient seek medical care (office visit, Urgent care, ER, hospitalized)   No treatment medication was reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-611877, US-MODERNATX, INC.-MOD-2022-611864, US-MODERNATX, INC.-MOD-2022-611805, US-MODERNATX, INC.-MOD-2022-611856 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2022: Live follow-up was received and included non-significant information (reporter last name and email address updated).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-611877:Patient 5 US-MODERNATX, INC.-MOD-2022-611864:Patient 4 US-MODERNATX, INC.-MOD-2022-611805:Patient 1 US-MODERNATX, INC.-MOD-2022-611856:Patient 3