Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: On completion of Paxlovid, asymptomatic. 3 days later, cold symptoms, then fever flu-l ke and 6 days later, positive Covid antigen test; COVID-19 treated with Paxlovid; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (On completion of Paxlovid, asymptomatic. 3 days later, cold symptoms, then fever flu-l ke and 6 days later, positive Covid antigen test) and COVID-19 (COVID-19 treated with Paxlovid) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Concurrent medical conditions included Hypothyroidism, Hyperlipidemia and Iodine contrast media allergy (Iodinated contrast). Concomitant products included SALBUTAMOL (ALBUTEROL HFA), LEVOTHYROXINE SODIUM (LEVOXYL), ESCITALOPRAM, LIOTHYRONINE and TRAZODONE for an unknown indication.  On 02-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (COVID-19 treated with Paxlovid). On 16-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (On completion of Paxlovid, asymptomatic. 3 days later, cold symptoms, then fever flu-l ke and 6 days later, positive Covid antigen test). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 09-May-2022 to 13-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (On completion of Paxlovid, asymptomatic. 3 days later, cold symptoms, then fever flu-l ke and 6 days later, positive Covid antigen test) had not resolved and COVID-19 (COVID-19 treated with Paxlovid) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2022, SARS-CoV-2 test: positive (Positive) Positive.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  The patient received unspecified medications/products within 2 weeks of starting COVID-19 treatment. It was reported that on completion of Paxlovid, the patient was asymptomatic. Three days later, the patient had cold symptoms, fever and flu-like symptoms and 6 days later, the patient tested positive for COVID antigen test. The device date was reported as 20-May-2022.  Company comment: This is a spontaneous case concerning a 59-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 (reported as COVID-19 and COVID-19 recurrent), which occurred after receiving a dose of mRNA-1273 as the fourth dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). The initial infection of COVID-19 occurred approximately 1 month after the fourth dose, while the event COVID-19 recurrent occurred 44 days post-vaccination. Patient was treated with Paxlovid for the initial COVID-19 infection for 5 days and became asymptomatic after. Three days later, patient started to have colds, fever, and flu-like symptoms and was tested positive for COVID-19. Patient reported that the event COVID-19 recurrent was not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 59-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 (reported as COVID-19 and COVID-19 recurrent), which occurred after receiving a dose of mRNA-1273 as the fourth dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). The initial infection of COVID-19 occurred approximately 1 month after the fourth dose, while the event COVID-19 recurrent occurred 44 days post-vaccination. Patient was treated with Paxlovid for the initial COVID-19 infection for 5 days and became asymptomatic after. Three days later, patient started to have colds, fever, and flu-like symptoms and was tested positive for COVID-19. Patient reported that the event COVID-19 recurrent was not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.