Sex: U
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Received Novavax 18-NOV-2022; tested positive for COVID-19; Diagnosed with COVID; tested positive for COVID; Night sweats; Loss of appetite; Migraine; Nasal congestion; Chills; Fever; Fatigue; Malaise; On 25-OCT-2023, this serious, initial spontaneous safety report was received from a consumer via a pharmaceutical company, and was received by Novavax on 07-NOV-2023.  An individual of an unspecified race, age, and sex was vaccinated with intramuscular Novavax COVID-19 Vaccine, Adjuvanted 10 ug/mL suspect COVID-19 vaccine dose 1 (dose 3 of COVID-19 vaccine) in the left arm on 18-NOV-2022.  Medical history included Systemic lupus erythematosus, which was in remission until the individual was vaccinated with Moderna COVID-19 vaccine (elasomeran) dose 1 on 10-FEB-2021 and dose 2 on 12-MAR-2021. Additional medical history included Migraine, Osteoporosis, and Drug hypersensitivity to sulfonamide and codeine.  Concomitant medications included Plaquenil (hydroxychloroquine sulfate) 200 mg (last dose taken on 18-OCT-2023) and Fosamax (alendronate sodium) 70 mg.  On an unreported date in OCT-2023, after vaccination, the individual experienced night sweats (PT: Night sweats), chills (PT: Chills), fever (PT: Pyrexia), loss of appetite (PT: Decreased appetite), fatigue (PT: Fatigue), malaise (PT: Malaise), migraine (PT: Migraine), and nasal congestion (PT: Nasal congestion). On 07-OCT-2023, the individual was diagnosed with COVID-19 at an urgent care facility, resulting in vaccination failure (PT: Vaccination failure) (Serious: Medically Significant) on 18-NOV-2022. Treatment of COVID-19 included Paxlovid (nirmatrelvir, ritonavir) from 09-OCT-2023 to 14-OCT-2023. The individual's symptoms improved 2 days after completing treatment. On 18-OCT-2023, the individual experienced the exact same symptoms that they had when they were diagnosed with COVID-19 at the urgent care facility. On an unreported day in OCT-2023, the individual tested for COVID-19 and was positive, and re-tested again 3 days later, and was still positive.  Relevant lab tests included a positive SARS-CoV-2 test on 07-OCT-2023, an unreported day in OCT-2023, and 3 days later on an unreported day in OCT-2023.  On 18-NOV-2022, the event of Vaccination failure was recovered/resolved.-On an unreported day in OCT-2023, the event outcomes of Pyrexia and Chills were recovered/resolved. At the time of reporting, the event outcomes of Night sweats, Decreased appetite, Fatigue, Malaise, Migraine, and Nasal congestion were recovering/resolving.; Sender's Comments: This individual of an unspecified age and sex experienced: Vaccination failure, COVID-19, Chills, Decreased appetite, Fatigue, Malaise, Migraine, Nasal congestion, Night sweats and Pyrexia after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Vaccination failure was assessed as serious. The events COVID-19, Chills, Decreased appetite, Fatigue, Malaise, Migraine, Nasal congestion, Night sweats and Pyrexia were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.