Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19/Tested COVID positive on 28-Dec-2021; Vaccination failure; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19/Tested COVID positive on 28-Dec-2021) and VACCINATION FAILURE (Vaccination failure) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022c21A and 014c21a) for COVID-19 vaccination.     The patient had no allergies (medications, food and other products). History relating to mentioned adverse event and both acute and chronic illnesses at the time of vaccination was reported as unknown. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, the patient experienced COVID-19 (COVID-19/Tested COVID positive on 28-Dec-2021) and VACCINATION FAILURE (Vaccination failure). At the time of the report, COVID-19 (COVID-19/Tested COVID positive on 28-Dec-2021) and VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, 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 were reported.  It was reported that the adverse event did not cause patient to seek medical care. The patient did not experienced a similar event in the past.   No treatment information was reported.  Company Comment: This spontaneous case concerns a 20-year-old male patient with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred approximately 7 months after receiving the second dose of mRNA-1273 vaccine. The patient was tested positive for SARS-CoV-2 as on 28-Dec-2021. Vaccination failure/Lack of efficacy is also noted in this case as it satisfies the criteria of LOE (LOE noticed 15 days after the second dose and the interval between the two doses is around 25-35 days with Moderna vaccine). Ongoing Pandemic could be confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-527278 (Patient Link).; Sender's Comments: This spontaneous case concerns a 20-year-old male patient with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred approximately 7 months after receiving the second dose of mRNA-1273 vaccine. The patient was tested positive for SARS-CoV-2 as on 28-Dec-2021. Vaccination failure/Lack of efficacy is also noted in this case as it satisfies the criteria of LOE (LOE noticed 15 days after the second dose and the interval between the two doses is around 25-35 days with Moderna vaccine). Ongoing Pandemic could be confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.