Received Sep 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| CHIK | CHIKUNGUNYA LIVE (IXCHIQ) | VALNEVA USA, INC. | UNK | — | IM |
The following information was received from a consumer on 25 Aug 2025. A 29-year-old female vaccinee received one dose of IXCHIQ (prevention of disease caused by chikungunya virus (CHIKV), batch number not reported) on 08 Aug 2025. The vaccinee experienced prolonged chikungunya-like symptoms for up to almost a month after vaccination. She had strong side effects, including fatigue, muscle/joint pains and aches and fever-like feelings (without a fever) for three weeks following the vaccination. Over two and a half weeks after the vaccination she developed an extremely swollen and painful lymph node above her collarbone wich made it hard to sleep, move her head or do normal activities. The outcome was reported as recovered.; Sender's Comments: The company assessed the non-serious events of prolonged chikungunya-like symptoms, fatigue, myalgia, arthralgia, fever-like feeling, and lymphadenopathy as possibly related to IXCHIQ vaccine administration, based on temporal association, the known safety profile, and clinical plausibility. These reported events, including longer lasting 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.