Received Aug 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (NOVAVAX)) | NOVAVAX | UNK | 6024MF020 | IM / LA |
| COVID19 | COVID19 (COVID19 (NOVAVAX)) | NOVAVAX | UNK | 6024MF020 | OT / LA |
Muscle pain; Disabling joint pain; Stiffness through all entire body and tightness; Difficulties in bending out and getting in and out of the car; In the left knee she had a tear in her meniscus; Loss of cartilage on the inside of the knee; ARTHRITIS; ASTHENIA; Arthritis flare up all over her body, specially in her Left knee and Right shoulder; Had overall severe fatigue; JOINT STIFFNESS; Bumps like a rash on her lower mouth lip; LIP PAIN; Loss of muscle strength in legs and right arm in particular; Stiffness through all entire body and tightness; OSTEOARTHRITIS; X-ray abnormal; On 10-Feb-2025, a non-serious initial Regulatory Authority report was received by a consumer or other non-health professional via Centers for Disease Control and Prevention (CDC Wonder) via Vaccine Adverse Event Reporting System (VAERS ID: 2825685-1) and was received by Novavax on 17-Mar-2025. A 71-year-old female who experienced "ARTHRITIS", "ASTHENIA", "CONDITION AGGRAVATED", "FATIGUE", "JOINT STIFFNESS", "LIP DISORDER", "LIP PAIN", "MUSCULAR WEAKNESS", "MUSCULOSKELETAL STIFFNESS", "OSTEOARTHRITIS" and "X-RAY ABNORMAL" on 02-Jan-2025 after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) on 27-Dec-2024. At the time of reporting, the outcome of the ARTHRITIS, ASTHENIA, CONDITION AGGRAVATED, FATIGUE, JOINT STIFFNESS, LIP DISORDER, LIP PAIN, MUSCULAR WEAKNESS, MUSCULOSKELETAL STIFFNESS, OSTEOARTHRITIS and X-RAY ABNORMAL was Not Recovered/Not resolved/Ongoing. The CDC's adverse event description (narrative) was provided as follows: Arthritis flare up all over body, especially in L knee and R shoulder. Stiffness in body, hips, thighs, knees, shoulders, arms, neck. Loss of muscle strength and weakness in both legs and R arm. Overall severe fatigue. Sore/bump on lower lip. On 22-Jul-2025 significant information was received from a consumer via contact center (MI No. NOV25-00549): Date of birth, height (170 centimeters) and weight (65.8 kilograms) and race were added. Added "Choroidal melanoma", "radiation treatment in the right eye only", "total left hip replacement", and "COVID-19 test (22-Jul-2023 and 02-Jul-2024)" in the patient's medical history. Added Pfizer vaccines to the patient's past therapy. Updated vaccine anatomical approach site from Left Arm to Left Deltoid. Updated vaccination facility details: facility name, address, city, postal code, telephone, and facility type. Updated concomitant medications reported terms from "daily women's 55+ multi-vitamin" to "New Chapter Every Woman's Multivitamin 55+ (Multivitamins, combinations)" and "glucosamine sulfate" to "Natural Factors Glucosamine sulfate (glucosamine sulfate)" Added the following events: "Disabling joint pain" (Arthralgia), "Muscle pain" (Myalgia), "Difficulties in bending out and getting in and out of the car" (Mobility decreases), "Stiffness through all entire body and tightness" (Muscle tightness), "In the left knee she had a tear in her meniscus" (Meniscus injury), and "Loss of cartilage on the inside of the knee" (Chondropathy). The onset dates of the events were unknown. Updated the following event verbatim terms: "Fatigue" to "Had overall severe fatigue", "Muscle weakness" to "Loss of muscle strength in legs and right arm in particular", "Musculoskeletal stiffness" to "Stiffness through all entire body and tightness", "Condition aggravated" to "Arthritis flare up all over her body, specially in her Left knee and Right shoulder", and "Lip disorder" to "Bumps like a rash on her lower mouth lip". Updated the severity of the event "Had overall severe fatigue" from unknown to Severe. The following treatments were added: "Disabling joint pain": Steroid injection on left knee to alleviate the pain on 24-Feb-2025, "Joint stiffness" and Physical therapy. On an unknown date, the patient's X-ray and MRI results showed osteoarthritis in her joints, and in the left knee, a tear in her meniscus and had loss of cartilage on the inside of the knee. At the time of reporting, the outcome of the events arthralgia, myalgia, mobility decreased, muscle tightness, meniscus injury and chondropathy was unknown.; Sender's Comments: This 71-year-old Female experienced Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis 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 Myalgia, Arthralgia, Muscle tightness, Mobility decreased, Meniscus injury, Chondropathy, X-ray abnormal, Arthritis, Asthenia, Condition aggravated, Fatigue, Joint stiffness, Lip disorder, Lip pain, Muscular weakness, Musculoskeletal stiffness and Osteoarthritis is considered possible.
Medical History/Concurrent Conditions: Arthritis; Choroid melanoma (Had radiation treatment in the Right eye only); COVID-19 rapid POC test positive; Radiation therapy; Total hip replacement
New Chapter Every Woman´s Multivitamin 55+; Natural Factors Glucosamine sulfate
Test Date: 20250128; Test Name: X-RAY; Result Unstructured Data: Moderate degenerative changes in the medial compartment.; Test Date: 20250204; Test Name: X-RAY; Result Unstructured Data: Moderate degenerative changes in the medial compartment.; Test Name: MRI; Result Unstructured Data: X-ray and MRI have shown she had osteoarthritis in her joints, and in the left knee she had a tear in her meniscus and had loss of cartilage on the inside of the knee.; Test Name: X-RAY; Result Unstructured Data: X-ray and MRI have shown she had osteoarthritis in her joints, and in the left knee she had a tear in her meniscus and had loss of cartilage on the inside of the knee.