Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Expired product administered, Interchange of vaccine products, Product expiration date issue, Product storage error
Clinical narrative: COVID-19; Patient received Moderna vaccine that had been expired for 2 weeks and stored in fridge on 17-May-2022; Patient had received a dose of JNJ COVID-19 vaccine prior to the mRNA-1273 vaccinations; the expiration date was not written on the vial and did not noticed it had already expired; Received the Moderna Covid 19 vaccine after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19), EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after manufacturer date of expiry), PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks and stored in fridge on 17-May-2022), INTERCHANGE OF VACCINE PRODUCTS (Patient had received a dose of JNJ COVID-19 vaccine prior to the mRNA-1273 vaccinations) and PRODUCT EXPIRATION DATE ISSUE (the expiration date was not written on the vial and did not noticed it had already expired) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A and 076C21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: JNJ (Patient received 1 dose of JNJ of Batch lot number is 1805031.) on 08-Mar-2021. Past adverse reactions to the above products included No adverse event with JNJ. Concurrent medical conditions included Allergy to antibiotic (Azithromycin.).   On 18-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after manufacturer date of expiry). On an unknown date, the patient experienced COVID-19 (COVID-19), PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks and stored in fridge on 17-May-2022), INTERCHANGE OF VACCINE PRODUCTS (Patient had received a dose of JNJ COVID-19 vaccine prior to the mRNA-1273 vaccinations) and PRODUCT EXPIRATION DATE ISSUE (the expiration date was not written on the vial and did not noticed it had already expired). At the time of the report, COVID-19 (COVID-19), EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after manufacturer date of expiry), PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks and stored in fridge on 17-May-2022), INTERCHANGE OF VACCINE PRODUCTS (Patient had received a dose of JNJ COVID-19 vaccine prior to the mRNA-1273 vaccinations) and PRODUCT EXPIRATION DATE ISSUE (the expiration date was not written on the vial and did not noticed it had already expired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  Patient received first and second booster of moderna vaccine.  The reporter stated that, found out that the vaccine had been expired for 2 weeks and the expiration date was not written on the vial and did not noticed it had already expired.  The vaccine stored in fridge on 17-May-2022.  The vials did not undergo any temperature excursion.  No treatment medications was provided by the reporter.  Company Comment:  This is a spontaneous case concerning a 59-year-old patient of an unknown gender with no relevant medical history reported, who experienced unexpected non-serious adverse event of special interest COVID-19 in the context of a dose of mRNA-1273 as third dose/second booster dose of COVID-19 vaccine. Latency cannot be properly assessed since event onset date was not provided. Patient had received a dose of JNJ COVID-19 vaccine with no reported adverse event, approximately 8 months prior to the first mRNA-1273 vaccination and 14 months prior to the second mRNA-1273 vaccination (Interchange of vaccine products). Additionally, Product storage error (described as Moderna vaccine had stored in fridge), Expired product administered (described as Moderna vaccine had been expired for 2 weeks) and Product expiration date issue (described as the expiration date was not written on the vial and did not noticed it had already expired) were also reported. Patient had a positive COVID-19 test on an unknown date. No further details about the clinical course and treatments were provided. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 59-year-old patient of an unknown gender with no relevant medical history reported, who experienced unexpected non-serious adverse event of special interest COVID-19 in the context of a dose of mRNA-1273 as third dose/second booster dose of COVID-19 vaccine. Latency cannot be properly assessed since event onset date was not provided. Patient had received a dose of JNJ COVID-19 vaccine with no reported adverse event, approximately 8 months prior to the first mRNA-1273 vaccination and 14 months prior to the second mRNA-1273 vaccination (Interchange of vaccine products). Additionally, Product storage error (described as Moderna vaccine had stored in fridge), Expired product administered (described as Moderna vaccine had been expired for 2 weeks) and Product expiration date issue (described as the expiration date was not written on the vial and did not noticed it had already expired) were also reported. Patient had a positive COVID-19 test on an unknown date. No further details about the clinical course and treatments were provided. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.