Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Received COVID-19 treatment, tested negative May 18 2022. Began experiencing symptoms again May 19. Tested positive again May 20.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Received COVID-19 treatment, tested negative May 18 2022. Began experiencing symptoms again May 19. Tested positive again May 20.) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014f21a) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE from 10-May-2022 to 14-May-2022 for an unknown indication.    On 18-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Received COVID-19 treatment, tested negative May 18 2022. Began experiencing symptoms again May 19. Tested positive again May 20.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 14-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Received COVID-19 treatment, tested negative May 18 2022. Began experiencing symptoms again May 19. Tested positive again May 20.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 test: negative (Negative) Tested negative. On 20-May-2022, SARS-CoV-2 test: positive (Positive) Tested positive.         Patient had experienced COVID 19 event on an unknown date in 2022.  The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  Company Comment: This spontaneous case concerns a 43-year-old, male patient, with no relevant medical conditions reported, who experienced an unexpected, non-serious COVID-19 approximately 7 months after vaccination with a 3rd dose of mRNA-1273 vaccine. A 5-day paxlovid treatment regimen started 7 months post-vaccination with a 3rd dose of mRNA-1273 vaccine. After 4 days of completing paxlovid treatment, the patient tested negative for COVID-19. The following day, patient experienced COVID-19 related symptoms. Patient tested positive with COVID-19 the day after his symptoms recurred. Event COVID-19 has not resolved. Further details on the medical history, clinical course, diagnostics, and treatment were not reported. The natural course of SARS-CoV-2 may include a brief recurrence of symptoms in some patients which is independent of treatment with paxlovid and regardless of vaccination status. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.; Sender's Comments: This spontaneous case concerns a 43-year-old, male patient, with no relevant medical conditions reported, who experienced an unexpected, non-serious COVID-19 approximately 7 months after vaccination with a 3rd dose of mRNA-1273 vaccine. A 5-day paxlovid treatment regimen started 7 months post-vaccination with a 3rd dose of mRNA-1273 vaccine. After 4 days of completing paxlovid treatment, the patient tested negative for COVID-19. The following day, patient experienced COVID-19 related symptoms. Patient tested positive with COVID-19 the day after his symptoms recurred. Event COVID-19 has not resolved. Further details on the medical history, clinical course, diagnostics, and treatment were not reported. The natural course of SARS-CoV-2 may include a brief recurrence of symptoms in some patients which is independent of treatment with paxlovid and regardless of vaccination status. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.