Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive covid test seven days after finishing Paxlovid treatment and testing negative on rapid and PCR; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive covid test seven days after finishing Paxlovid treatment and testing negative on rapid and PCR) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Type 1 diabetes mellitus and Drug allergy. Concomitant products included INSULIN and PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) for an unknown indication.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 11-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On 16-May-2022, NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive covid test seven days after finishing Paxlovid treatment and testing negative on rapid and PCR). At the time of the report, COVID-19 (Positive covid test seven days after finishing Paxlovid treatment and testing negative on rapid and PCR) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         The patient was taking some other medications/products within 2 weeks of starting COVID-19 treatment. No treatment medications were provided by the reporter.  Company comment: This spontaneous case concerns a 42-year-old male patient with relevant medical history of Type1 diabetes mellitus, who experienced the unexpected non-serious AESI of COVID-19, approximately 13 months after receiving a second dose of mRNA-1273 vaccine and six months after receiving a dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE). Initially, the patient was treated with Paxlovid (Nirmatrelvir + Ritonavir) for COVID19; however, patient again tested positive for COVID-19 seven days after finishing treatment with Paxlovid. Outcome of the event was reported as resolving. Details of first dose, symptoms, clinical course, further investigation reports were not provided. Ongoing COVID-19 pandemic could be a confounder and underlying medical history of Type1 diabetes mellitus could be a risk factor. Approximately seven months after mRNA-1273 vaccination, the patient had received one dose of TOZINAMERAN / PFIZER BIONTECH COVID-19 VACCINE (Interchange of vaccine products) which could be an additional risk factor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 42-year-old male patient with relevant medical history of Type1 diabetes mellitus, who experienced the unexpected non-serious AESI of COVID-19, approximately 13 months after receiving a second dose of mRNA-1273 vaccine and six months after receiving a dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE). Initially, the patient was treated with Paxlovid (Nirmatrelvir + Ritonavir) for COVID19; however, patient again tested positive for COVID-19 seven days after finishing treatment with Paxlovid. Outcome of the event was reported as resolving. Details of first dose, symptoms, clinical course, further investigation reports were not provided. Ongoing COVID-19 pandemic could be a confounder and underlying medical history of Type1 diabetes mellitus could be a risk factor. Approximately seven months after mRNA-1273 vaccination, the patient had received one dose of TOZINAMERAN / PFIZER BIONTECH COVID-19 VACCINE (Interchange of vaccine products) which could be an additional risk factor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.