Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025BZ1A) for COVID-19 vaccination. Concurrent medical conditions included Sulfonamide allergy (Sulfa). Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication. On 09-Apr-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 23-May-2022 to 28-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 02-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was reported that, the patient had a persistent bitter taste constant in his mouth during the entire 5-day course of Paxlovid. On 31 May 2022 Monday, patient had negative rapid testing and was asymptomatic. On 02 Jun 2022, Thursday, approximately 5 days after finishing treatment with Paxlovid, the patient tested positive for COVID-19 again. After testing positive again, the patient had sinus symptoms and other such COVID 19 symptoms as well. Company comment: This is a spontaneous case concerning a 42-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred approximately 13 months after the first dose of mRNA-1273 vaccine administration. The event was described as, approximately 409 days after the first dose of mRNA-1273 vaccine administration patient took 5-day course of Nirmatrelvir+ Ritonavir (Paxlovid) for treatment of Covid-19. Approximately 3 days after the last dose, patient was tested negative on Covid-19 rapid test. However, approximately 2 days after, patient was tested positive again for Covid-19 and subsequently experienced Covid-19 symptoms such as sinus symptoms. No other information surrounding the event was reported. The outcome of the event was reported as resolving. The current Covid-19 pandemic remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 42-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious  event of Covid-19. The event occurred approximately 13 months after the first dose of mRNA-1273 vaccine administration. The event was described as, approximately 409 days after the first dose of mRNA-1273 vaccine administration patient took 5-day course of Nirmatrelvir+ Ritonavir (Paxlovid) for treatment of Covid-19. Approximately 3 days after the last dose, patient was tested negative on Covid-19 rapid test. However, approximately 2 days after, patient was tested positive again for Covid-19 and subsequently experienced Covid-19 symptoms such as sinus symptoms. No other information surrounding the event was reported. The outcome of the event was reported as resolving. The current Covid-19 pandemic remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.