Received Jul 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (NOVAVAX)) | NOVAVAX | UNK | 6024MF012 | OT / RA |
Made her sick for about 4 or 5 days; It made her feel achy; She had quite a sore arm; She still has a small lump in the area where she received her 20 FEB 2025 vaccine; This case, received on 13-Sep-2024 was assessed as invalid for the following reason: no adverse event. Additional significant information was received on 20-Jun-2025, from a consumer via contact center (Case No. NOV25-00467). This case has been reassessed as valid based on the follow-up information received. Adverse events were added. Updated the patient's DOB, patient's race. Added the following in the patient medical history: FIBROMYALGIA, EHLERS DANLOS SYNDROME (HYPERMOBILITY SUBTYPE), CHRONIC NEUTROPHILLIC LEUKOCYTOSIS, and CHRONIC FATIGUE SYNDROME. Updated therapy site to Arm and Vaccine Anatomical Approach Site to Right Arm for both therapies. Updated vaccination facility details of the vaccine received on 13-Sep-2024. Added the new Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) vaccine received on 25-Feb-2025. Added 2 new events experienced from the mRNA COVID-19 vaccines in the patient past therapy: "She could not tolerate the mRNA COVID-19 vaccines as well" (Adverse event), "Made her feel achy - kind of like when she got an mRNA COVID-19 vaccine" (Pain). Added events experienced with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula): on unspecified dates, the patient reported experiencing "Made her sick for about 4 or 5 days" (Illness), "It made her feel achy" (Pain), "She had quite a sore arm" (Pain in extremity), "She still has a small lump in the area where she received her 20 FEB 2025 vaccine" (Injection site mass) on unspecified dates. At the time of reporting, the outcome of the events was unknown.; Sender's Comments: This Female of an unspecified age experienced Illness, Pain, Pain in extremity and Injection site mass after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Illness was reported as non-serious. The event Pain was reported as non-serious. The event Pain in extremity was reported as non-serious. The event Injection site mass was 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 Illness, Pain, Pain in extremity and Injection site mass is considered Possible.
Chronic fatigue syndrome; Ehlers-Danlos syndrome; Fibromyalgia; Leukocytosis