Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: My symptoms had almost entirely abated by the end of my 5-day Paxlovid course (started 1 day after onset of symptoms); This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (My symptoms had almost entirely abated by the end of my 5-day Paxlovid course (started 1 day after onset of symptoms)) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included ATORVASTATIN and DULOXETINE for an unknown indication, ASPIRIN [ACETYLSALICYLIC ACID].    In April 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (My symptoms had almost entirely abated by the end of my 5-day Paxlovid course (started 1 day after onset of symptoms)). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 18-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (My symptoms had almost entirely abated by the end of my 5-day Paxlovid course (started 1 day after onset of symptoms)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2022, SARS-CoV-2 test: positive (Positive) Positive with a very faint signal on days 8. On 22-May-2022, SARS-CoV-2 test: positive (Positive) Positive with a very faint signal on days 9. On 23-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 26-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 27-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 28-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.   No treatment medications were reported Device Date was reported as 28-May-2022  Company comment-This spontaneous case concerns a 53-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19 from 14th to 18th May2022. He had started Paxlovid one day after onset of symptoms of covid. He continued to be rapid antigen positive and was negative on day 10 of Paxlovid treatment. Two days later fatigue , cough, rhinorrhoea occurred with a positive antigen test on day 15. 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 53-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19 from 14th to 18th May2022. He had started Paxlovid one day after onset of symptoms of covid. He continued to be rapid antigen positive and was negative on day 10 of Paxlovid treatment. Two days later fatigue , cough, rhinorrhoea occurred with a positive antigen test on day 15. 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.