Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Dyspnoea, Electrocardiogram, Headache
Clinical narrative: Heart pain; Complex narrow tachycardia; PVC; PAC; Dysautonomia; Shortness of breath; Insomnia; Loss of smell; Shaking; Sweating; Loss of appetite; Diarrhea; Chills; Nausea; Headaches; This serious, initial spontaneous safety report was received by Novavax on 27-FEB-2024 from a consumer via the web portal.  A 38-year-old female was vaccinated in the left deltoid with intramuscular Novavax COVID-19 Vaccine, Adjuvanted 10 ug/mL suspect COVID-19 vaccine dose 1 on 23-NOV-2022 (dose 4 of COVID-19 vaccine) and dose 2 (dose 5 of COVID-19 vaccine) on 01-FEB-2023 at a pharmacy.  Medical history included SARS-CoV-2 test positive on 27-DEC-2021. The individual was previously vaccinated with Pfizer BioNTech COVID-19 vaccine (tozinameran) dose 1 on 08-APR-2021, dose 2 on 29-APR-2021, and dose 3 (booster) on 12-NOV-2021. She had no ongoing or past health conditions or allergies.  The individual was not taking any concomitant medications.  On an unspecified date, after vaccination, the individual experienced heart pain (PT: Angina pectoris) (Serious: Hospitalization and Medically Significant), complex narrow tachycardia (PT: Tachycardia) (Serious: Hospitalization), PVC (premature ventricular contractions) (PT: Ventricular extrasystoles) (Serious: Hospitalization), PAC (premature atrial contractions) (PT: Supraventricular extrasystoles) (Serious: Hospitalization), dysautonomia (PT: Autonomic nervous system imbalance) (Serious: Hospitalization), nausea (PT: Nausea) (Serious: Hospitalization), headaches (PT: Headache) (Serious: Hospitalization), shortness of breath (PT: Dyspnoea) (Serious: Hospitalization), insomnia (PT: Insomnia) (Serious: Hospitalization), loss of smell (PT: Anosmia) (Serious: Hospitalization), shaking (PT: Tremor) (Serious: Hospitalization), sweating (PT: Hyperhidrosis) (Serious: Hospitalization), chills (PT: Chills) (Serious: Hospitalization), loss of appetite (PT: Decreased appetite) (Serious: Hospitalization), and diarrhea (PT: Diarrhoea) (Serious: Hospitalization). The individual was hospitalized on an unspecified date for 1 day. As the cause of hospitalization was not specified, the seriousness criterion of Hospitalization was assessed for all events. Treatment for the events included 3 emergency visits and fluids.  The following lab tests were performed on unspecified dates, with no results reported: Electrocardiogram and Cardiac monitoring.  At the time of reporting, the event outcomes of Angina pectoris, Tachycardia, Ventricular extrasystoles, Supraventricular extrasystoles, Autonomic nervous system imbalance, Nausea, Headache, Dyspnoea, Insomnia, Anosmia, Tremor, Hyperhidrosis, Chills, Decreased appetite, and Diarrhoea were not recovered/not resolved.; Sender's Comments: This 38 year-old female experienced: Angina pectoris, Anosmia, Autonomic nervous system imbalance, Chills, Decreased appetite, Diarrhoea, Dyspnoea, Headache, Hyperhidrosis, Insomnia, Nausea, Supraventricular extrasystoles, Tachycardia, Tremor and Ventricular extrasystoles after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The events Angina pectoris, Anosmia, Autonomic nervous system imbalance, Chills, Decreased appetite, Diarrhoea, Dyspnoea, Headache, Hyperhidrosis, Insomnia, Nausea, Supraventricular extrasystoles, Tachycardia, Tremor and Ventricular extrasystoles were reported as 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.