Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: re-tested-positive following a negative test. Symptoms appear to be mild; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (re-tested-positive following a negative test. Symptoms appear to be mild) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017e21a, O11m20A and O11m20A) for COVID-19 vaccination.     The patient's past medical history included Palindromic rheumatism. Concurrent medical conditions included Drug allergy (unspecified drug). Concomitant products included HYDROXYCHLOROQUINE (HYDROXYCHLOROQUIN) from 01-Dec-2020 to 27-May-2022 for an unknown indication.   On 02-Feb-2021 at 3:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021 at 4:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021 at 12:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022 at 4:00 AM, the patient experienced COVID-19 (re-tested-positive following a negative test. Symptoms appear to be mild). At the time of the report, COVID-19 (re-tested-positive following a negative test. Symptoms appear to be mild) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2022, SARS-CoV-2 test: positive Positive. On an unknown date, SARS-CoV-2 test: negative Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Co suspect drug name given as Pfizer for treatment of COVID-19 from 15-May-2022 to 19-May-2022. Concomitant drug Amneal was reported with active substance Hydroxychoroquine form 01-Dec-2020 to 27-may-2022.  Patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  Patient reported that dysgeusia and re-tested-positive following a negative test.  Company Comment: This is a spontaneous case concerning  a  60-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred 217 days after the third dose of mRNA-1273 COVID 19 Vaccine. Patient tested positive for SARS-CoV-2 test. Patient was treated with Pfizer for treatment of COVID-19 from 15-May-2022 to 19-May-2022. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning  a  60-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred 217 days after the third dose of mRNA-1273 COVID 19 Vaccine. Patient tested positive for SARS-CoV-2 test. Patient was treated with Pfizer for treatment of COVID-19 from 15-May-2022 to 19-May-2022. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.