Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Expired product administered, Product storage error, SARS-CoV-2 test
Clinical narrative: Covid-19; Vaccine was expired 2 weeks before the administration date and was stored and refrigerator on 17-May-2022; Vaccine was administered on 17-May-2022 and found out that the vaccine had been expired 2 weeks ago; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Covid-19), PRODUCT STORAGE ERROR (Vaccine was expired 2 weeks before the administration date and was stored and refrigerator on 17-May-2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 17-May-2022 and found out that the vaccine had been expired 2 weeks ago) in a 23-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 083J21A and 083J21A) for COVID-19 vaccination.     Patient had no known drug allergies (NKDA).    On 19-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 17-May-2022 and found out that the vaccine had been expired 2 weeks ago). On an unknown date, the patient experienced COVID-19 (Covid-19) and PRODUCT STORAGE ERROR (Vaccine was expired 2 weeks before the administration date and was stored and refrigerator on 17-May-2022). At the time of the report, COVID-19 (Covid-19), PRODUCT STORAGE ERROR (Vaccine was expired 2 weeks before the administration date and was stored and refrigerator on 17-May-2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 17-May-2022 and found out that the vaccine had been expired 2 weeks ago) 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 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Number of doses/vials: 26 doses some were primary doses and some boosters.  On 17-May-2022, the vial was stored in fridge.  The vial did not undergo any temperature excursions.  Reporter stated that none of patient had reported side effects.  No treatment information was reported.  Company Comment: This spontaneous case concerns a 23-year-old patient of unknown gender with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred on unspecified interval after receiving the second dose of mRNA-1273 vaccine. Product storage error and Expired product administered were reported as additional events. Patient received the first dose of mRNA-1273 vaccine within the recommended dosing interval of 28 days. The onset date of COVID-19, clinical course, diagnostic investigations, and treatment details were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 23-year-old patient of unknown gender with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred on unspecified interval after receiving the second dose of mRNA-1273 vaccine. Product storage error and Expired product administered were reported as additional events. Patient received the first dose of mRNA-1273 vaccine within the recommended dosing interval of 28 days. The onset date of COVID-19, clinical course, diagnostic investigations, and treatment details were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.