Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Guillain-Barre syndrome, Inflammation, Pain in extremity, Peripheral swelling
Clinical narrative: I have a strange inflammation in my body; I got Plantar fasciitis; Plantar fasciitis; I couldn't put the glove on my right hand and it was swollen; I have inflammation in my finger/I can't bend it; I couldn't walk/dragging my feet on the floor; My legs were hurting/pain in left foot/pain in right finger; I got very strange symptoms like Guillian-Barre syndrome; I was choking on my saliva; This serious initial Spontaneous safety report from country was received by Novavax on 06-Jun-2024 from a Consumer or other non-health professional via Contact Center.  A 61-year-old Female was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted (Intramuscular) (LOT: 4302MF023) on 02-Sep-2022 and (LOT: 4302MF023) on 21-Sep-2022.  The following medical history was reported: HIGH CHOLESTEROL.  The following concomitant medication was reported: BABY ASPIRIN (acetylsalicylic acid), Statin for cholesterol.  On an unspecified date in 2022 after vaccination the patient experienced I have a strange inflammation in my body(Inflammation), On an unspecified date in 2022, 2 Weeks after vaccination the patient experienced I got Plantar fasciitis(Plantar fasciitis),  I couldn't put the glove on my right hand and it was swollen(Peripheral swelling), and I have inflammation in my finger/I can't bend it(Inflammation). On an unspecified date in 2022, 3 Days after vaccination the patient experienced I couldn't walk/dragging my feet on the floor (Gait inability), and My legs were hurting/pain in left foot/pain in right finger (Pain in extremity). On an unspecified date in 2022 after vaccination the patient experienced I got very strange symptoms like Guillian-Barre syndrome (Guillain-Barre syndrome) (Serious: Medically significant) and I was choking on my saliva (Salivary hypersecretion).  Relevant lab tests included: COVID-19 VIRUS TEST POSITIVE (Result: Positive).  At the time of reporting, the event outcome of Inflammation was Unknown, Plantar fasciitis was Unknown, Peripheral swelling was Unknown, Inflammation was Not Recovered/Not Resolved/Ongoing, Gait inability was Unknown, Pain in extremity was Not Recovered/Not Resolved/Ongoing, Guillain-Barre syndrome was Unknown and Salivary hypersecretion was Recovered/Resolved.  A discrepancy was identified in the source document regarding the site of administration for Therapy #1 and #2. It was reported to be on the LEFT SIDE - this is not available on the structured field; LEFT ARM was captured instead.; Sender's Comments: This 61 year-old Female experienced Guillain-Barre syndrome, Inflammation, Plantar fasciitis, Peripheral swelling, Inflammation, Gait inability, Pain in extremity and Salivary hypersecretion after vaccination with Novavax COVID-19 Vaccine, Adjuvanted(1).  The event Guillain-Barre syndrome was reported as serious.  The events Inflammation, Plantar fasciitis, Peripheral swelling, Inflammation, Gait inability, Pain in extremity and Salivary hypersecretion were reported as non-serious.   Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted and Guillain-Barre syndrome, Inflammation, Plantar fasciitis, Peripheral swelling, Inflammation, Gait inability, Pain in extremity and Salivary hypersecretion is considered Possible.