Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022; No adverse event; Given vaccine which was beyond the 30 day use by date; given vaccine which underwent temperture excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022), EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion) and NO ADVERSE EVENT (No adverse event) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Sep-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion). On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022), EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion) 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 PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022), EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date) and PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion).    Concomitant medication list was not provided. Public health representative reported that one of their providers had a lot number which underwent temperature excursion on 15-Aug-2022 to 17-Aug-2022 and this was administered to 17 patients after the incident. Monovalent product was administered. Individual vials with vial size of 5.5ml. The vial was initially stored in the refrigerator on 15-Aug-2022. Storage condition at the time of the excursion was in fridge. Maximum or minimum temperatures reached, as applicable was 0.29C (cold excursion). Excursion duration was 32 hours and 30 min. Disposed now as it was expired. Treatment information was not provided.  This case is of 17th patient.   This case was linked to US-MODERNATX, INC.-MOD-2022-682168 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2022: Live significant follow up: added patient demographic details, updated suspect product dose details. Narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682168:MOD22-030301, MOD22-030312