Age: 19.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 17-Nov-2022, first punctured on 18-Nov-2022 at 9:05 am and was administered on 21-Nov-2022 at 9:45 am; No adverse event; Dose administered more than 12 hours post puncture/Dose administered after exposure to room temperature more than 24 hours; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture/Dose administered after exposure to room temperature more than 24 hours), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Nov-2022, first punctured on 18-Nov-2022 at 9:05 am and was administered on 21-Nov-2022 at 9:45 am) and NO ADVERSE EVENT (No adverse event) in a 19-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1) on 11-Apr-2021, Pfizer (Dose 2) on 02-May-2021 and Pfizer (1st booster) on 11-Dec-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy (Sulfa), Peanut allergy (Peanut oil), Shellfish allergy and Allergy to nuts.    On 21-Nov-2022 at 9:45 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Nov-2022 at 9:45 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture/Dose administered after exposure to room temperature more than 24 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Nov-2022, first punctured on 18-Nov-2022 at 9:05 am and was administered on 21-Nov-2022 at 9:45 am) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture/Dose administered after exposure to room temperature more than 24 hours), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Nov-2022, first punctured on 18-Nov-2022 at 9:05 am and was administered on 21-Nov-2022 at 9:45 am) 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 (Dose administered more than 12 hours post puncture/Dose administered after exposure to room temperature more than 24 hours) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Nov-2022, first punctured on 18-Nov-2022 at 9:05 am and was administered on 21-Nov-2022 at 9:45 am).    The patient never had COVID positive test or diagnosis. No Medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Dose administered was from a vial that was left out at room temperature over the weekend, and after 72 hours stored at room temperature. Dose was also administered more than 12 hours post puncture (first punctured on 18-Nov-2022 at 9:05 am, and administered to this patient on 21-Nov-2022 around 9:45 am).  The vial size was 2.5 ml. The vial was initially stored in the refrigerator on 17-Nov-2022. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 72 hours. The vial was stored post puncture at room temperature. No symptoms were reported, and patient was not under any regular or concomitant medication. No treatment medication was provided.