Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive on a home test; took Moderna booster on 26Nov2021 and tested positive for COVID on 27Dec2021; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive on a home test) and DRUG INEFFECTIVE (took Moderna booster on 26Nov2021 and tested positive for COVID on 27Dec2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 031A21A) for COVID-19 vaccination.     It was reported that patient has no allergies, no medical history and no other vaccines taken within 1 month prior to Moderna COVID-19 vaccine.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, the patient experienced COVID-19 (tested positive on a home test) and DRUG INEFFECTIVE (took Moderna booster on 26Nov2021 and tested positive for COVID on 27Dec2021). At the time of the report, COVID-19 (tested positive on a home test) and DRUG INEFFECTIVE (took Moderna booster on 26Nov2021 and tested positive for COVID on 27Dec2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive. In January 2022, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medications were reported. It was reported that, the other people on her trip were sick and tested positive, but she did not get sick. The patient stated she scheduled her second booster of Moderna for this coming Wednesday 06-Apr-2022. No treatment medications were reported.  Company comment:  This spontaneous case concerns a 62-year-old female patient, with no reported medical history, who experienced the non-serious, unexpected AESI of COVID-19. The patient received primary series (first and second dose) of mRNA 1273 COVID-19 Vaccine with 28 days interval, 7 months after the second dose, had the booster dose of mRNA 1273 vaccine. The patient had a mild case of COVID-19 infection and tested positive on a home test 8 months after the second dose of mRNA 1273 COVID-19 vaccine (1 month after the booster dose). Patient did not seek medical care for COVID-19 infection, and 1 week after, she tested negative in the COVID-19 test. Additional event of Drug ineffective was captured in this case. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62-year-old female patient, with no reported medical history, who experienced the non-serious, unexpected AESI of COVID-19. The patient received primary series (first and second dose) of mRNA 1273 COVID-19 Vaccine with 28 days interval, 7 months after the second dose, had the booster dose of mRNA 1273 vaccine. The patient had a mild case of COVID-19 infection and tested positive on a home test 8 months after the second dose of mRNA 1273 COVID-19 vaccine (1 month after the booster dose). Patient did not seek medical care for COVID-19 infection, and 1 week after, she tested negative in the COVID-19 test. Additional event of Drug ineffective was captured in this case. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.