Reporte zur Charge UJB01AA

Symptomtext

No adverse event; Nurse is calling to report that patient received expired vaccine on 12-JUN-2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that patient received expired vaccine on 12-JUN-2023) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis. Co-suspect products included non-company products PEDIARIX for an unknown indication, HIB VACCINE CONJ (TET TOX) (ACTHIB) for an unknown indication and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for an unknown indication. No Medical History information was reported. On 12-Jun-2023, the patient received third dose of PEDIARIX (Intramuscular) 1 dosage form, third dose of HIB VACCINE CONJ (TET TOX) (ACTHIB) (Intramuscular) 1 dosage form and third dose of PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) (Intramuscular) 1 dosage form. On 12-Jun-2023 at 10:00 AM, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Jun-2023 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that patient received expired vaccine on 12-JUN-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that patient received expired vaccine on 12-JUN-2023) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that patient received expired vaccine on 12-JUN-2023). Event Outcome was given as Recovered and date of recovery was given as 12-Jun-2023 No concomitant information was reported. No treatment information was provided. Suspect product dosage text was reported as unknown. The 2.5ml vial was initially stored in refrigerator on 09-Jun-2023 and did not underwent temperature excursions. This case is reported for 6 month old baby. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2023-728850 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2023: Follow-up information received and reporter information updated, secondary reporter details was added. Patient details and dose details were updated, other co suspects were added; Sender's Comments: US-MODERNATX, INC.-MOD-2023-728850:69-year-old patient