Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: They had a excursion on 4-Jun-2022; Vial was expired on 13-Jul-2022 and refrigerated on 17-Jul & 18-Jul-2022; Vaccine was expired on 13-Jul-2022 and administered on 19-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 19-Jul-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (They had a excursion on 4-Jun-2022) and PRODUCT STORAGE ERROR (Vial was expired on 13-Jul-2022 and refrigerated on 17-Jul & 18-Jul-2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     It was unknown if the patient had any allergies to medications, food, and other products. It was unknown if the patient had ever been diagnosed with or tested positive for COVID-19.   The patient had no medical history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination. It was unknown if the patient was given any other vaccines within 1 month prior to Moderna COVID-19 vaccine.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-Jul-2022 and administered on 19-Jul-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (They had a excursion on 4-Jun-2022) and PRODUCT STORAGE ERROR (Vial was expired on 13-Jul-2022 and refrigerated on 17-Jul & 18-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-Jul-2022 and administered on 19-Jul-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (They had a excursion on 4-Jun-2022) and PRODUCT STORAGE ERROR (Vial was expired on 13-Jul-2022 and refrigerated on 17-Jul & 18-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that vaccine expired on 13-Jul-2022 was administered to the patient. It was patient's second booster dose. The vial had undergone a temperature excursion on 04-Jun-2022. There were 3 affected vials and the date the vial initially stored in the refrigerator was 17-Jul-2022, and 18-Jul-2022.   At the time of the excursion, the storage condition was frozen storage. The maximum or minimum temperatures reached, as applicable was reported as Maximum 5.8 degree F. The duration of the excursion was 15 minutes. It was reported that the currently those vials were wasted and 1 vial was stored. The vaccines did not have a change in state and were still frozen.  It was unknown if the adverse events caused the patient to seek medical care and it was unknown if the patient had experienced a similar event in the past.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-611805, US-MODERNATX, INC.-MOD-2022-611848, US-MODERNATX, INC.-MOD-2022-611856, US-MODERNATX, INC.-MOD-2022-611877 (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 were updated).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-611805:Patient 1 US-MODERNATX, INC.-MOD-2022-611848:Patient 2 US-MODERNATX, INC.-MOD-2022-611856:Patient 3 US-MODERNATX, INC.-MOD-2022-611877:Patient 5