Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Breakthrough COVID-19, Chills, Device dislocation, Fatigue
Clinical narrative: COVID-19; took rapid test; positive; Malpositioned IUD; Sore throat; Some nasal discharge; runny nose; Really feeling achy; COVID-19; took rapid test; positive; sick with COVID; Shivering; Muscle pain; dull aching in arm and muscles on right side of back; 4 on a scale of 10; general muscle pain (whole body), 7 on a scale of 10; Muscle pain; Headache (6 on a scale of 10); Malaise (5 on a scale of 10); not feeling well; Fatigue (5 on a scale of 10); Fever; Took temp; 101.6; This non-serious, initial spontaneous safety report was received by Novavax on 13-NOV-2023 from a consumer. On 14-NOV-2023, additional information was received from a consumer.  A 46-year-old female was vaccinated with intramuscular Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect COVID-19 vaccine dose 1 (dose 4 of COVID-19 vaccine) in the right arm on 12-NOV-2023 at a pharmacy.  Medical history included COVID-19 on an unreported day in JUN-2022, confirmed via rapid antigen test, Anxiety, and Headache. Previous COVID-19 vaccinations included Moderna COVID-19 vaccine (elasomeran) dose 1 on 16-APR-2021, dose 2 on 14-MAY-2021, and dose 3 (booster) on 31-DEC-2021. At the time of vaccination, the individual was recovering from a Muscle strain in the back, which started on an unreported date and recovered on 13-NOV-2023.  Concomitant medications included buspirone 60 mg orally twice daily since MAY-2023, and propranolol 20 mg orally daily since JUL-2023.  On 12-NOV-2023, about 5-6 hours after vaccination, the individual experienced muscle pain, with a dull aching in her arm and muscles on right side of her back (PT: Myalgia), rating the severity at bedtime a 4 on a scale of 10, with 1 being the least and 10 being the most severe. She took an unspecified routine over-the-counter dose recommendation of aspirin as treatment for the muscle pain. On 13-NOV-2023, 1 day after vaccination the individual woke with general muscle pain in her whole body (7 on a scale of 10), malaise (5 on a scale of 10) (PT: Malaise), fatigue (5 on a scale of 10) (PT: Fatigue), and a headache (6 on a scale of 10) (PT: Headache). She took an additional unspecified routine over-the-counter dose recommendation of aspirin as treatment for the events.  On 14-NOV-2023, in the evening, the event outcomes of Myalgia, Malaise, Fatigue, and Headache were recovered/resolved.  Lot number was requested but was unknown to the reporter.  On 26-FEB-2024, significant additional information was received by Novavax from a consumer. On 27-FEB-2024, non-significant additional information was received by Novavax from a consumer. The following information has been updated in the case: The individual's date of birth was updated.  Additional medical history included an unspecified Hypersensitivity.  Concomitant medications were updated to include an additional dosage, as follows: buspirone 30 mg orally twice daily since an unspecified day in 2023 and propranolol 10 mg orally as needed three times daily since an unspecified day in 2023.  On 23-FEB-2024, 3 months 11 days after vaccination, the individual had a malpositioned IUD (PT: Device dislocation). On 25-FEB-2024, the individual began feeling a sore throat (PT: Oropharyngeal pain) and had some nasal discharge (PT: Rhinorrhoea), which the individual thought was possibly related to allergies. On 26-FEB-2024 at 2 AM, the individual woke and did not feel well (PT: Malaise), so she took Tylenol (acetaminophen) as treatment. At 8 AM, the individual woke and felt really achy (PT: Pain) and was shivering (PT: Chills), and had sore throat, runny nose, and muscle pain (PT: Myalgia). At 8:00 AM, the individual took her temperature, which was 101.6 (no units reported) and had a fever (PT: Pyrexia). The same day, the individual had a headache (PT: Headache). At 8:30 AM, she took a rapid SARS-CoV-2 test, which was positive (PT: Breakthrough COVID-19). The event PT: Vaccination failure (Serious: Medically Significant) on 15-NOV-2023 was added; therefore, the case was upgraded to serious.  On 15-NOV-2023, the event outcome of Vaccination failure was recovered/resolved. At the time of reporting, the event outcomes of Device dislocation, Oropharyngeal pain, Rhinorrhoea, Malaise, Pain, Chills, Myalgia, Pyrexia, Headache, and Breakthrough COVID-19 were not recovered/not resolved.; Sender's Comments: This 46 year-old female experienced: Vaccination failure, Myalgia, Fatigue, Headache, Malaise, Device dislocation, Oropharyngeal pain, Rhinorrhoea, Breakthrough COVID-19, Chills, Pain and Pyrexia after vaccination with Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter. The event Vaccination failure was assessed as serious. The events Myalgia, Fatigue, Headache, Malaise, Device dislocation, Oropharyngeal pain, Rhinorrhoea, Breakthrough COVID-19, Chills, Pain and Pyrexia were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) and the reported events is considered Possible.