Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Feeling hot, Headache
Clinical narrative: She has now developed coughing and wheezing; She has now developed coughing and wheezing; She was having difficulty standing up straight on Friday  - she was "wobbly" and had to hold onto the wall to walk.; Felt "not so well"; She passed out in the early evening on Friday; She was nauseated; Horrible, pounding headache on the right side of her head; Experienced feeling hot; Chills; She measured her temperature, which was 101.4 F; Pain her left arm where she received the vaccine; This serious initial spontaneous safety report was received by Novavax on 07-Oct-2024 from a consumer or other non health professional.  A 79 year-old female was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula)(Intramuscular) (Lot number was requested but was unknown to the reporter) on 02-Oct-2024.  The following medical history was reported: URINARY TRACT INFECTION.   The following concomitant medication was reported: NITROFURANTOIN (nitrofurantoin).  On 03-Oct-2024, 2 days after vaccination, the patient experienced Pain her left arm where she received the vaccine (Pain in extremity), On 04-Oct-2024, 3 days after vaccination, the patient experienced She passed out in the early evening on Friday (Loss of consciousness)(Serious: Other Medically Important Condition), Felt "not so well" (Malaise), She was nauseated (Nausea), Horrible, pounding headache on the right side of her head (Headache), feeling hot (Feeling hot), Chills (Chills), She measured her temperature, which was 101.4 F (Pyrexia), She was having difficulty standing up straight on Friday  - she was "wobbly" and had to hold onto the wall to walk. (Muscular weakness). On 06-Oct-2024 ,5 days after vaccination the patient experienced She has now developed coughing and wheezing (Cough) and She has now developed coughing and wheezing(Wheezing).  At the time of reporting, the event outcome of Pain in extremity was Recovered/Resolved on 06-Oct-2024, Loss of consciousness was Recovered/Resolved on 04-Oct-2024, Malaise was Recovered/Resolved on 06-Oct-2024, Nausea was Recovered/Resolved on 06-Oct-2024, Headache was Recovered/Resolved on 06-Oct-2024, Feeling hot was Recovered/Resolved on 06-Oct-2024, Chills was Recovered/Resolved on 06-Oct-2024, Pyrexia was Recovered/Resolved on 06-Oct-2024, Muscular weakness was Recovered/Resolved on 06-Oct-2024, Cough was Not Recovered/Not Resolved/Ongoing, and Wheezing was Not Recovered/Not Resolved/Ongoing.; Sender's Comments: This 79 year-old female experienced Pain in extremity, Loss of consciousness, Malaise, Nausea, Headache, Feeling hot, Chills, Pyrexia, Muscular weakness, Cough and Wheezing after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  The event Loss of consciousness was reported as serious.  The events Pain in extremity, Loss of consciousness, Malaise, Nausea, Headache, Feeling hot, Chills, Pyrexia, Muscular weakness, Cough and Wheezing 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 Loss of consciousness, Pain in extremity, Malaise, Nausea, Headache, Feeling hot, Chills, Pyrexia, Muscular weakness, Cough and Wheezing is considered Possible.