Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (rebound symptoms and positive antigen recurred) in a 57-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Diabetes and Drug allergy. Concomitant products included METFORMIN for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (rebound symptoms and pos. antigen recurred). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 15-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (rebound symptoms and pos. antigen recurred) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) positive antigen recurred 11 day. On an unknown date, SARS-CoV-2 test: positive (Positive) positive antigen. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. It was reported that medication helped immediately but symptoms and positive antigen recurred on 11 days. Device Date was reported as 26-May-2022. Company Comment: This is a spontaneous case concerning a 57-year-old, female patient with Concurrent medical conditions of Diabetes, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred on an unknown date after the unspecified dose of mRNA-1273 COVID 19 Vaccine. Patient tested positive twice for SARS-CoV-2 test. Patient was treated with nirmatrelvir, ritonavir from 15-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. It was reported that medication helped immediately but symptoms and positive antigen recurred on 11 days. The event outcome was reported as unknown. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The concurrent medical condition of Diabetes remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. Sender's Comments: Company Comment: This is a spontaneous case concerning a 57-year-old, female patient with Concurrent medical conditions of Diabetes, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred on n unknown date after the unspecified dose of mRNA-1273 COVID-19 Vaccine. Patient tested positive twice for SARS-CoV-2 test. Patient was treated with nirmatrelvir, ritonavir from 15-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. It was reported that medication helped immediately but symptoms and positive antigen recurred on 11 days. The event outcome was reported as unknown. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The concurrent medical condition of Diabetes remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.