Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: vial was initially stor2022 and administered on 14Nov2022ed in the refrigerator on 13-Oct-; No adverse event; Administration error:  patient administered with Moderna bivalent beyond use date/ dose was administered beyond use date on 14Nov2022. Vaccines were stored in fridge since 13Oct2022; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administration error:  patient administered with Moderna bivalent beyond use date/ dose was administered beyond use date on 14Nov2022. Vaccines were stored in fridge since 13Oct2022), PRODUCT STORAGE ERROR (vial was initially stor2022 and administered on 14Nov2022ed in the refrigerator on 13-Oct-) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 14-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administration error:  patient administered with Moderna bivalent beyond use date/ dose was administered beyond use date on 14Nov2022. Vaccines were stored in fridge since 13Oct2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stor2022 and administered on 14Nov2022ed in the refrigerator on 13-Oct-) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administration error:  patient administered with Moderna bivalent beyond use date/ dose was administered beyond use date on 14Nov2022. Vaccines were stored in fridge since 13Oct2022), PRODUCT STORAGE ERROR (vial was initially stor2022 and administered on 14Nov2022ed in the refrigerator on 13-Oct-) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Administration error:  patient administered with Moderna bivalent beyond use date/ dose was administered beyond use date on 14Nov2022. Vaccines were stored in fridge since 13Oct2022) and PRODUCT STORAGE ERROR (vial was initially stor2022 and administered on 14Nov2022ed in the refrigerator on 13-Oct-).    No concomitant medication information was provided.  It was reported that Individual vials or unbroken cartons was Individual vials, Vial size was 2.5ml Date the vial was initially stored in the refrigerator was 13-Oct-2022. Vial did not undergo any temperature excursions. 4 patients were administered beyond use date.  No treatment medications were provided   This case was linked to US-MODERNATX, INC.-MOD-2022-673345, US-MODERNATX, INC.-MOD-2022-673344 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673345: US-MODERNATX, INC.-MOD-2022-673344:Same reporter