Received Sep 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| CHIK | CHIKUNGUNYA LIVE (IXCHIQ) | VALNEVA USA, INC. | UNK | — | — |
The following information was received from a consumer on 25 Aug 2025. A 40-year-old female vaccinee received one dose of IXCHIQ (prevention of disease caused by chikungunya virus (CHIKV), batch number not reported) on 21 Aug 2025. She started having some moderate neck/shoulder pain and mild headache on 24 Aug 2025 and had an elevated temperature (about two degrees Fahrenheit) and an elevated resting heart rate (about 10 beats per minute higher than what is normal for her). The patient went for a challenging run on Sunday (24 Aug 2025) which may have put some additional stress on her body that contributed to the symptoms. The patient was reportedly in excellent health otherwise. She still had the headache and neck pain the morning of this report.; Sender's Comments: The company assessed the non-serious listed events of arthralgia, headache and body temperature increased, and the unlisted events of neck pain and heart rate increased as possibly related to IXCHIQ vaccine administration due to temporal association and clinical plausibility. The events occurred 3 days after vaccination in an otherwise healthy patient and may be consistent with post-vaccination systemic reactions or chikungunya-like adverse reactions. Of note, although the patient experienced neck pain and headache along with increased body temperature, no other meningitis-like symptoms were reported to suggest a neurological involvement in this case. Furthermore, the patient's reported physical exercise on the day of the symptoms' onset may be a possible contributory factor in the events' occurrence. All of the reported symptoms, are already included in the IXCHIQ reference safety information and are consistent with chikungunya like adverse reactions described in the label and in clinical trials.