Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Paxlovid was given for treatment of COVID-19/positive again. Experienced moderate to severe symptoms for 4-5 days, and tested positive for 9 days; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Paxlovid was given for treatment of COVID-19/positive again. Experienced moderate to severe symptoms for 4-5 days, and tested positive for 9 days) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (The patient had allergy to unspecified past drug).    On 04-May-2022 at 10:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Paxlovid was given for treatment of COVID-19/positive again. Experienced moderate to severe symptoms for 4-5 days, and tested positive for 9 days). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 05-May-2022 to 09-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 23-May-2022, COVID-19 (Paxlovid was given for treatment of COVID-19/positive again. Experienced moderate to severe symptoms for 4-5 days, and tested positive for 9 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2022, SARS-CoV-2 test: negative (Negative) Tested negative day after completing Paxlovid course, on day 6 of COVID infection. On 11-May-2022, SARS-CoV-2 test: negative (Negative) Tested negative again next day.. In May 2022, SARS-CoV-2 test: positive (Positive) Tested positive for 9 days.         No concomitant medications were reported.  It was reported that, the patient tested negative day after completing Paxlovid course, on day 6 of COVID infection. On the next day, the patient again tested negative. Later, the next day patient went back to work. On 13-May-2022 at 04:00 PM (two days later), patient developed symptoms, however patient did not test again till two days later and was positive again. The patient experienced moderate to severe symptoms for 4-5 days and tested positive for 9 days.  Company comment: This spontaneous case reported by a patient, concerns a 60-year-old male patient with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 (Paxlovid was given for treatment of COVID-19/positive again. Experienced moderate to severe symptoms for 4-5 days, and tested positive for 9 days), 01 day after receiving the 4 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Details of previous doses was not provided. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for 5 days for COVID-19 treatment. A day after completing the Paxlovid course, SARS-CoV-2 test was negative for 2 consecutive days. It was reported that on an unknown date in May 2022, SARS-CoV-2 test was again tested positive. The patient experienced moderate to severe symptoms for 4-5 days and tested positive for 9 days. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This spontaneous case reported by a patient, concerns a 60-year-old male patient with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 (Paxlovid was given for treatment of COVID-19/positive again. Experienced moderate to severe symptoms for 4-5 days, and tested positive for 9 days), 01 day after receiving the 4 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Details of previous doses was not provided. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for 5 days for COVID-19 treatment. A day after completing the Paxlovid course, SARS-CoV-2 test was negative for 2 consecutive days. It was reported that on an unknown date in May 2022, SARS-CoV-2 test was again tested positive. The patient experienced moderate to severe symptoms for 4-5 days and tested positive for 9 days. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report. Event seriousness assessed per medical judgement.