Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Drug allergy (Unknown drug.). Concomitant products included LOSARTAN POTASSIUM (LOSARTAN ZYDUS), FISH OIL (ORTHOMEGA), AIRBORNE, CALCIUM, VITAMIN D [VITAMIN D NOS] and VITAMIN B [VITAMIN B NOS] for an unknown indication.   On 02-Apr-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021 at 5:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for COVID). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 17-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Positive. On 18-May-2022, SARS-CoV-2 test: positive (Positive) Tested positive for COVID after taking all doses as prescribed of Paxlovid..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Active drug substance name of Zydus was reported as losartan 50mg. The patient received Moderna booster on 27-Dec-2021. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Tested positive for COVID after taking all doses as prescribed of Paxlovid. Device Date was reported as 18-May-2022.  Company comment: This spontaneous case concerns a 57-year-old female patient, with no reported relevant medical history, who experienced, unexpected, non-serious, ADR of COVID-19, approximately 5 months after receiving mRNA-1273 vaccine as a third dose.  The patient reported receiving Dose 1 and Dose 2 with a 28-day interval, and the third dose given approximately 8 months after receiving Dose 2 of mRNA-1273 vaccine.  The patient was treated with Nirmatrelvir-Ritonavir (Paxlovid) for five days at an unspecified dose and frequency. On the 6th day after completing the course of Paxlovid, the patient tested positive for COVID-19.  The event had not resolved.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 57-year-old female patient, with no reported relevant medical history, who experienced, unexpected, non-serious, ADR of COVID-19, approximately 5 months after receiving mRNA-1273 vaccine as a third dose.  The patient reported receiving Dose 1 and Dose 2 with a 28-day interval, and the third dose given approximately 8 months after receiving Dose 2 of mRNA-1273 vaccine.  The patient was treated with Nirmatrelvir-Ritonavir (Paxlovid) for five days at an unspecified dose and frequency. On the 6th day after completing the course of Paxlovid, the patient tested positive for COVID-19.  The event had not resolved.  The benefit-risk relationship of mRNA-1273 is not affected by this report.