Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date and time vial was first punctured on 23Jan2023 around 1 PM and date and time of administration of vaccine on 24Jan2023 around 10 AM and 10:30 AM 8, the vial was stored post puncture in fridge.; No Adverse Event; Patient was given expired Moderna vaccine. A vial was punctured and inadvertently left in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given expired Moderna vaccine. A vial was punctured and inadvertently left in the fridge), PRODUCT STORAGE ERROR (Date and time vial was first punctured on 23Jan2023 around 1 PM and date and time of administration of vaccine on 24Jan2023 around 10 AM and 10:30 AM 8, the vial was stored post puncture in fridge.) and NO ADVERSE EVENT (No Adverse Event) in a 51-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 046H22A) for COVID-19 prophylaxis.     Patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) from 24-Jan-2023 to an unknown date for an unknown indication.   On 24-Jan-2023, 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 24-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given expired Moderna vaccine. A vial was punctured and inadvertently left in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time vial was first punctured on 23Jan2023 around 1 PM and date and time of administration of vaccine on 24Jan2023 around 10 AM and 10:30 AM 8, the vial was stored post puncture in fridge.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given expired Moderna vaccine. A vial was punctured and inadvertently left in the fridge), PRODUCT STORAGE ERROR (Date and time vial was first punctured on 23Jan2023 around 1 PM and date and time of administration of vaccine on 24Jan2023 around 10 AM and 10:30 AM 8, the vial was stored post puncture in fridge.) 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 EXPIRED PRODUCT ADMINISTERED (Patient was given expired Moderna vaccine. A vial was punctured and inadvertently left in the fridge) and PRODUCT STORAGE ERROR (Date and time vial was first punctured on 23Jan2023 around 1 PM and date and time of administration of vaccine on 24Jan2023 around 10 AM and 10:30 AM 8, the vial was stored post puncture in fridge.).    On 15-Apr-2021, the patient received first dose of Moderna Covid-19 Vaccine (unknown route) 1 dosage form. On 13-May-2021, received second dose of Moderna Covid-19 Vaccine (unknown route) dosage was 1 dosage form.  It was reported that, the vaccinator accidentally used the punctured vial on the following day. Dose was administered more than 12 hours post puncture. The vial was initially stored in the refrigerator on 17Jan2023 was the date they received the thawed vaccine. The bag says best use by date was 12Feb2023. The vial was first punctured on 23Jan2023 around 1 PM and administration of vaccine was on 24Jan2023 around 10 AM and 10:30 AM. The vial was stored in fridge post puncture and did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range was only to draw doses.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-705025 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-705025:Second Patient case