Sex: U
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, COVID-19 immunisation, Cough, Fatigue, Insomnia
Clinical narrative: Vaccination failure; Pfizer Dose 1: 16-MAR-2021, Dose 2: 6-APR-2021; Novavax COVID-19 booster; Covid-19 one month after getting the Novavax COVID-19 booster; it was mild it wasn't great; 3 severe insomnia for months; 3 bad coughs; Severe tiredness; extreme fatigue; This non-serious, initial spontaneous safety report was received by Novavax on 22-AUG-2023 from a consumer, via the contact center.  A female of 51 years was vaccinated with intramuscular use Novavax Covid-19 Vaccine and Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 3 (reported as booster) on an unspecified date in 2022 on the left side, at a pharmacy.  Medical history included a drug allergy to codeine, COVID-19 (tested positive on 09-JAN-2022), dose 1 of Pfizer BioNTech COVID-19 vaccine (tozinameran) received intramuscularly on 16-MAR-2021, and dose 2 of Pfizer BioNTech COVID-19 vaccine received intramuscularly on 06-APR-2021; both doses received at the age of 49 on the left side. Dose 2 resulted in the individual experiencing fatigue and dizziness.  The following concomitant medications were reported: low dose of Lexapro (escitalopram oxalate), magnesium, unspecified vitamin 3, and a lot of supplements for brain.  On an unspecified date in 2022, the individual received a Novavax covid-19 booster, following 2 doses of Pfizer BioNTech COVID-19 vaccine (PT: COVID-19 immunisation). The booster dose resulted in severe tiredness which was resolved within 5-6 hours after vaccination (PT: Fatigue). On 01-JAN-2023, 1 month after vaccination, the individual tested positive for Covid-19 (PT: Breakthrough COVID-19).  Relevant lab tests included: SARS-CoV-2 test (Result: Positive; 01-JAN-2023 and 09-JAN-2022).  At the time of reporting, the event outcomes of Fatigue and COVID-19 immunisation were recovered/resolved, and the event outcome of Breakthrough COVID-19 was unknown.  On 15-FEB-2024, significant additional information was received by Novavax from a consumer via the contact center. The following information has been updated in the case: The individual's weight was updated. The individual was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted dose 1 (dose 3 of COVID-19 vaccine) on an unreported day in NOV-2022 (before 24-NOV-2022 [Thanksgiving]).  Medical history was updated to include Fatigue and Dizziness after dose 1 of Pfizer BioNTech COVID-19 vaccine.  The individual reported she experienced extreme fatigue within 45 minutes of receiving each vaccine and she would have to go to bed. The LLT: Tiredness was updated to LLT: Fatigue, and the start date was updated to an unspecified day in NOV-2022. The individual also provided additional information regarding Breakthrough COVID-19. She reported it was mild and it wasn't great. On an unspecified day in JAN-2023, the individual had 3 severe insomnia for months (PT: Insomnia) and 3 bad coughs (PT: Cough). The event PT: Vaccination failure (Serious: Medically Significant) on an unspecified day in NOV-2022 was added; therefore, the case was upgraded to serious.  At the time of reporting, the event outcomes of Breakthrough COVID-19, Insomnia, Cough, and Vaccination failure were recovered/resolved.  On 24-JAN-2024, the individual was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) dose 2 (dose 4 of COVID-19 vaccine). Associated adverse event information can be found in manufacturer control number (MCN) 2024NVX-US-000000270.; Sender's Comments: This 51-year-old female experienced: Vaccination failure, COVID-19 immunisation, Fatigue, Breakthrough COVID-19, Cough and Insomnia after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Vaccination failure was assessed as serious. The events COVID-19 immunisation, Fatigue, Breakthrough COVID-19, Cough and Insomnia 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.