Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Two patients were given expired Moderna vaccine. A vial was punctured and inadvertently left in the fridge; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Two patients were given expired Moderna vaccine. A vial was punctured and inadvertently left in the fridge) and NO ADVERSE EVENT (No adverse event) in a 36-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.     No Medical History information was reported.   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, the patient experienced EXPIRED PRODUCT ADMINISTERED (Two patients were given expired Moderna vaccine. A vial was punctured and inadvertently left in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Two patients were given expired Moderna vaccine. A vial was punctured and inadvertently left in the 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 Route), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Two patients were given expired Moderna vaccine. A vial was punctured and inadvertently left in the fridge).    Information about previous COVID-19 vaccination doses included Moderna doses on 29-Apr-2021 and 21-May-2021.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Two patients were given expired Moderna vaccine. A vial was punctured and inadvertently left in the fridge. The vaccinator accidentally used the punctured vial on the following day. The HCP was advised by her rep to call Moderna to make sure that the patients can be revaccinated. She wants to know if the patients need to be revaccinated. She has not contacted the patients yet, so she doesn't know if they experienced any adverse reactions. Bivalent dose administered >12 hours post puncture, vial size was unknown, date the vial was initially stored in the refrigerator reported as 17-Jan-2023 which was the date they received the thawed vaccine. The bag said "today's date is 13-Jan-2023" and "Best use by date is 12-Feb-2023". Date and time vial was first punctured was 23-Jan-2023 at around 1 PM. Date and time of administration of vaccine reported as 24-Jan-2023 at around 10 AM and 10:30 AM. Vial was stored inside the fridge post puncture. The vial had not undergone any temperature excursions. The vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) only to draw doses.   This case was linked to US-MODERNATX, INC.-MOD-2023-705040 (Linked Report).  This case was linked to MOD-2023-705161 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-705040:Second patient case