Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 038B21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, Heart disorder, Obesity and Allergy (Allergy to unspecified drug). Concomitant products included METOPROLOL SUCCINATE (TOPROL XL) from 14-Jan-2022 to an unknown date, LOSARTAN from 06-Jan-2022 to an unknown date, WARFARIN SODIUM (COUMADIN) from 22-Nov-2021 to an unknown date, BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) from 22-Oct-2021 to an unknown date and LEVOTHYROXINE SODIUM (SYNTHROID) from 22-Nov-2021 to an unknown date for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 12-Apr-2022 to 16-Apr-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2022, SARS-CoV-2 test: positive (Positive) Paxlovid on day 2 after testing positive. In April 2022, SARS-CoV-2 test: negative (Negative) neg on day 10. On an unknown date, SARS-CoV-2 test: negative (Negative) Took me 20 days to neg test on antigen test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient on Paxlovid on day 2 after testing positive. Feeling fine while taking medicine aside from few minor symptoms. Patient Tested negative on day 10 and 3 days later - Started feeling ill again and much more severe than when first diagnosed. Congestion, cough, fatigue, muscle aches. Patient took 20 days to negative on antigen test. Treatment received for the adverse events was cough medicine.  Company Comment: This spontaneous case concerns a 56-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 12-Apr-2022 to 16-Apr-2022. She was tested positive 2 days after the treatment with Paxlovid. Patient Tested negative on day 10 and 3 days later she started feeling ill again with Congestion, cough, fatigue, muscle aches. After 20 days tested negative for covid antigen test. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 56-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 12-Apr-2022 to 16-Apr-2022. She was tested positive 2 days after the treatment with Paxlovid. Patient Tested negative on day 10 and 3 days later she started feeling ill again with Congestion, cough, fatigue, muscle aches. After 20 days tested negative for covid antigen test. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.