Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive after completing Paxlovid treatment) and INTERCHANGE OF VACCINE PRODUCTS (She had Johnson and Johnson vaccine then had Moderna booster) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Johnson and Johnson (which was a farce). Past adverse reactions to the above products included No adverse event with Johnson and Johnson. Concomitant products included TRAZODONE for Sleep difficult, ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (She had Johnson and Johnson vaccine then had Moderna booster). On 13-May-2022, the patient experienced COVID-19 (tested positive after completing Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 05-May-2022 to 09-May-2022 for COVID-19 treatment, at a dose of 1 dosage form twice a day. At the time of the report, COVID-19 (tested positive after completing Paxlovid treatment) and INTERCHANGE OF VACCINE PRODUCTS (She had Johnson and Johnson vaccine then had Moderna booster) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2022, SARS-CoV-2 test: negative (Negative) tested Negative 2 days later. On 11-May-2022, SARS-CoV-2 test: negative (Negative) Negative and felt great. On 13-May-2022, SARS-CoV-2 test: positive (Positive) felt sick and took a test and it was positive. On 14-May-2022, SARS-CoV-2 test: tested positive on both tests (Positive) two different brands at home test, tested positive on both tests. In May 2022, SARS-CoV-2 test: positive (Positive) tested again and was positive. Patient is sitting in the hospital getting monoclonal antibody right now that is Bebtelovimab 175 mg. Patient confirm Patient was not admitted to hospital only there for monoclonal antibody treatment. Patient saw another doctor since her doctor not available. Patient husband was a day and half behind her and he got the same anti-body treatment and was really sick prior to the antibody treatment. Is there a product complaint to report? Yes. Company Comment: This spontaneous case reported by a consumer concerns a 60-year-old female patient, with history of previously administered Covid-19 vaccine Johnson and Johnson (interchange of vaccine products), who experienced unexpected, non-serious AESI Covid-19, approximately 8 months after receiving a booster dose of mRNA-1273. She was treated with Paxlovid after which she felt good and tested negative for Covid-19. However, around 2 days later she felt sick again, with unspecified symptoms described as worse than before. She did 2 different brands of home tests for Covid-19 and tested positive on both. She was then treated with Bebtelovimab.  The outcome is unknown. The ongoing Covid-19 pandemic could be a contributory factor. The benefit risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case reported by a consumer concerns a 60-year-old female patient, with history of previously administered Covid-19 vaccine Johnson and Johnson (interchange of vaccine products), who experienced unexpected, non-serious AESI Covid-19, approximately 8 months after receiving a booster dose of mRNA-1273. She was treated with Paxlovid after which she felt good and tested negative for Covid-19. However, around 2 days later she felt sick again, with unspecified symptoms described as worse than before. She did 2 different brands of home tests for Covid-19 and tested positive on both. She was then treated with Bebtelovimab. The outcome is unknown. The ongoing Covid-19 pandemic could be a contributory factor. The benefit risk relationship of mRNA-1273 is not affected by this report.