Age: 53.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Electrocardiogram, Heart rate increased, Hyperhidrosis, Impaired work ability, Insomnia
Clinical narrative: I was missing days at work; Bilateral dependent subsegmental atelectasis; Elevated WBC; Rapid heart rate; I had developed Brugada Pattern; Brugada syndrome; Not able to sleep; Lung inflammation; Coughing/ Chest pressure cough/ Coughing worsened/ Coughing all the time; Coughing, Chest pressure cough; Feeling of pressure and chest and lungs/feeling of squeezing of pressure on chest/felt like I had elephant on my chest; Feeling of pressure and chest and lungs; Sweating; Chills; This serious initial Spontaneous report was received by Novavax on 06-Nov-2024 from a consumer or other non-health professional via Novavax Medical Information (MI number NOV24-00764).   A 53-year-old Female was vaccinated with intramuscular Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) (LOT: 6024MF016A) on 26-Oct-2024.  The following interacting medications were reported: Influenza Vaccine (influenza vaccine).  The following medical history was reported: HYPOTHYROIDISM, ECZEMA, SEASONAL ALLERGIES, RAGWEED AND POLLEN ALLERGY, DOGS and CATS ALLERGY, MEDICATION ALLERGY with NEOMYCIN, and NEOSPORIN, and COVID-19 RAPID ANTIGEN TEST POSITIVE.  No concomitant medications were reported.  On 26-Oct-2024, the same Day after vaccination the patient experienced Sweating (Hyperhidrosis), and Chills (Chills).  On 27-Oct-2024, 1 Day after vaccination the patient experienced Coughing/ Chest pressure cough/ Coughing worsened/ Coughing all the time (Cough), and Feeling of pressure and chest and lungs/feeling of squeezing of pressure on chest/felt like I had elephant on my chest (Chest discomfort).  On 28-Oct-2024, the patient's cough and feeling of squeezing of pressure on chest worsened. The patient started on albuterol inhaler and an unspecified cough medicine.  On 31-Oct-2024, 5 Days after vaccination, the patient experienced Lung inflammation (Pneumonitis)(Serious: Other Medically Important Condition). Wixella (fluticasone propionate and salmeterol) was prescribed.   On 01-Nov-2024, the patient went to see an allergist and Airspura (albuterol) was also prescribed.  On 02-Nov-2024, 7 Days after vaccination the patient experienced Not able to sleep (Insomnia). On the same day, the patient continued to experience chest pressure and cough and was treated with methylprednisone.  On an unspecified date after vaccination the patient was missing days at work (Impaired work ability).  On 03-Nov-2024, 8 Days after vaccination, the patient experienced Brugada syndrome (Brugada syndrome) (Serious: Other Medically Important Condition), Elevated WBC(White blood cell count increased), Rapid heart rate (Heart rate increased), and Bilateral dependent subsegmental atelectasis (Atelectasis).  On 04-Nov-2024, the chest pressure and cough continued and the patient was switched from Wixella (fluticasone propionate and salmeterol) to nebulizer to use albuterol and budesonide.  On 05-Nov-2024, the patient consulted a cardiologist where the Brugada pattern was still showing and a low dose of aspirin was prescribed.  Relevant lab tests included: UNSPECIFIED TEST (Result: Confirmed lung inflammation, Test Date: 31-Oct-2024), BREATHING TEST (Result: Confirmed lung inflammation, Test Date: 01-Nov-2024), BREATHING TEST (Result: Confirmed lung inflammation, Test Date: 01-Nov-2024), ULTRASOUND (Result: did not show a blood clot but showed bilateral dependent subsegmental atelectasis. Test Date: 03-Nov-2024), LABORATORY TEST (Result: Normal except for elevated WBC, Test Date: 03-Nov-2024), WBC (Result: elevated, Test Date: 03-Nov-2024), EKG(Result: showed newly developed Brugada pattern to heart beat, Test Date: 03-Nov-2024), EKG(Result: did not show abnormal pattern, Test Date: 15-Aug-2024) and EKG(Result: Brugada pattern is still showing, Test Date: 05-Nov-2024).  At the time of reporting, the event outcome of Impaired work ability, Hyperhidrosis, Chills, Insomnia, Heart rate increased, White blood cell count increased, and Atelectasis was Unknown, Cough, and Chest discomfort was Recovering/Resolving, while Pneumonitis and Brugada syndrome was Not Recovered/Not Resolved/Ongoing.; Sender's Comments: This 53-year-old Female experienced Impaired work ability, Hyperhidrosis, Chills, Cough, Chest discomfort, Pneumonitis, Insomnia, Brugada syndrome, White blood cell count increased, Heart rate increased and Atelectasis after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  The events Pneumonitis and Brugada syndrome were assessed as serious.  The events Impaired work ability, Hyperhidrosis, Chills, Cough, Chest discomfort, Insomnia, White blood cell count increased, Heart rate increased and Atelectasis were reported as non-serious.   Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Pneumonitis, Brugada syndrome, Hyperhidrosis, Chills, Cough, Chest discomfort, Insomnia, White blood cell count increased, Heart rate increased, Atelectasis and Impaired work ability is considered Possible.