Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The used vials were placed in the refrigerator on the same day of administration; No adverse event; Dose administered after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (The used vials were placed in the refrigerator on the same day of administration) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 070H21A, 018B21A and 036A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Mar-2021 at 12:23 PM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 20-Dec-2021 at 8:26 PM, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 05-Apr-2022 at 2:52 PM, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On 07-Jun-2022, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jun-2022 at 2:38 PM,  after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The used vials were placed in the refrigerator on the same day of administration) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (The used vials were placed in the refrigerator on the same day of administration) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (The used vials were placed in the refrigerator on the same day of administration).    Concomitant product use was not provided by the reporter.  Patient had never been diagnosed with or  tested positive for COVID-19.  It is unknown that patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if patient had any Chronic or long-standing health conditions. It was unknown if patient had taken any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination and or at the time of the adverse event.  The vial was initially stored in the refrigerator on 21Jan2022.  The event did not cause the patient to seek medical care.  It was unknown that the adverse event most likely caused by mRNA-1273.  It was unknown if there was any other potential causes.  It was unknown if the patient experienced a similar event in the past.  The used vials were placed in the refrigerator on the same day of administration on 07-Jun-2022.  The vial did not undergo any temperature excursions.  Treatment information was not provided.