Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Neuropathy peripheral, Paraesthesia
Clinical narrative: Neuropathy; Sinus pressure; Drowsiness; Insomnia from post-covid returns; Chills; Feverish; Significant headache; Tingling; arm falling asleep for hours (another post-covid symptom); This serious, initial spontaneous safety report was received by Novavax on 02-DEC-2023 from a consumer via the web portal.  An female of 39 years was vaccinated with intramuscular use Novavax Covid-19 Vaccine and Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect Covid-19 vaccine dose 1 (dose 5 of COVID-19 vaccine) on 22-OCT-2023 in the left arm at a pharmacy.  The following medical history was reported: Allergy to animal, Diabetes mellitus, Seasonal allergy and Urticaria and previous Covid vaccinations with Pfizer BioNTech COVID-19 vaccine (tozinameran) dose 1 on  23-APR-2021 in the left arm, dose 2 on 16-MAY-2021 in the left arm, dose 3 (booster dose 1) on 21-NOV-2021 in the left arm and dose 4 (booster dose 2) on 22-AUG-2022 in the left arm.   The following concomitant medications were reported: Ozempic (semaglutide), metformin, vitamin D NOS, zinc, a probiotic (bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus), and an unspecified women's multi-vitamin.  On 23-OCT-2023, 1 day after vaccination, the individual experienced feverish (PT: Pyrexia), sinus pressure (PT: Paranasal sinus discomfort), drowsiness (PT: Somnolence) and chills (PT: Chills). On 25-OCT-2023, 3 days after vaccination, the individual had a significant headache (PT: Headache) and her post-Covid insomnia returned (PT: Insomnia). On 26-OCT-2023, 4 days after vaccination, the individual experienced neuropathy/tingling/arm falling asleep for hours, which was another post-covid symptom (PT: Neuropathy peripheral) (Serious: Medically Significant) (PT: Paraesthesia). On 27-OCT-2023, chills, feverish, sinus pressure and drowsiness returned. From 28-OCT-2023 onwards, the occasional insomnia returned.  Relevant lab tests included: SARS-CoV-2 test (Result: Positive; 10-SEP-2022).  At the time of reporting, the event outcomes of Chills, Pyrexia, Paranasal sinus discomfort, Somnolence, Paraesthesia, Headache and Neuropathy peripheral were recovered with sequelae on unspecified dates, and the event outcome of Insomnia was not recovered/not resolved.  This case was reported as non-serious, but the event PT of Neuropathy peripheral was assessed as serious as it was identified to be on the regulatory authority's Important Medical Events (IME) list.; Sender's Comments: This 39 year-old female experienced: Neuropathy peripheral, Chills, Paranasal sinus discomfort, Pyrexia, Somnolence, Headache, Insomnia and Paraesthesia after vaccination with Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter. The event Neuropathy peripheral was assessed as serious. The events Chills, Paranasal sinus discomfort, Pyrexia, Somnolence, Headache, Insomnia and Paraesthesia 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.