Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| CHIK | CHIKUNGUNYA LIVE (IXCHIQ) | VALNEVA USA, INC. | UNK | 24B011 | IM |
Severe musculoskeletal pain; Mild headache; Mild malaise; Injection site tenderness both application sites; The following information was received from a physician on 02 Dec 2024. A 56-year-old male received one dose of IXCHIQ (prevention of disease caused by chikungunya virus (CHIKV), batch number 24B011) i.m. on 25 Nov 2025 into the right deltoid muscle. Co-suspect vaccinations included COMIRNATY (COVID-19 vaccine) and FLUCELVAX TRIVAL (Influenza vaccine) on the same day, both into the left deltoid muscle. Ten days before he received one dose of Typhim Vi (Typhoid vaccine) and Adacel (Tetanus, Diphtheria and Pertussis vacccine) with mild to moderate injection site pain. Three weeks before administration of IXCHIQ he had a mild cold. Past drug history included seven vaccinations against COVID, annually vaccination against Influenza (for the last 10 years), vaccination against MMR, TDPA, Hepatitis A and B. Adverse reactions were limited to injection site pain and one or two occasions of flu-like symptoms. On 25-Nov-2024 he developed injection site tenderness at both injection sites. On 28 Nov 2025 he experienced moderate musculoskeletal pain of an overall dull but somewhat burning character. At the same time, there he noted an increase in injection site pain for IXCHIQ. It was most pronounced between shoulder blades and on the proximal limbs (here most noticeable on the upper back of the thighs when sitting), but also on the distal upper limbs. There was no arthralgia. The pain persisted at rest but allowed to sleep before it escalated to severe during the day, preventing daily activties. Additional symptoms included mild malaise and mild headache; the latter was worsened by shaking the head. There was no fever or other systemic symptom. The adverse reactions were left untreated, decreased to moderate during 29 Nov 2024 and resolved on 30 Nov 2024.; Reporter's Comments: This spontaneous case was reported by a consumer / pharmacovigilance expert and describes the occurrence of severe musculoskeletal pain as well as mild headache, fatigue and injection site tenderness in a 56 year-old male who was vaccinated with IXCHIQ (Lot no., 24B011) against Chikungunya virus infection. Co-suspect products included COMIRNATY 0.5mL (2024-2025 formula, LOT no. LN0588) for Covid 19 vaccination and FLUCELVAX TRIVAL 2024-2025 (LOT no. 391416) for Influenza vaccination. The consumer had no relevant medical history, a mild cold had resolved three weeks before IXCHIQ application, and there were no concurrent conditions or concomitant drugs. Previously used drugs included numerous vaccintions against COVID (x7), Influenza (annually for last 10 years), MMR, TDAP, Hepatitis A and B. In the vast majority of these vaccine applications, adverse reactions were limited to injection site pain with only one or two occasions of flu-like symptoms. Ten days prior to IXCHIQ vaccination the patient had addtionally received vaccines against Typhoid (Typhim Vi, Lot no. unknown), as well as against Tetanus, Diphtheria and Pertussis (Adacel, Lot X2A421M) with mild to moderate injection on site pain as the only adverse drug reactions. On 25-NOV-2024 at 8:10am, the consumer was injected with IXCHIQ 0.5 mL, into the right deltoid muscle. Within 30 minutes COMIRNATY and FLUCELVAX were injected, both into the left deltoid muscle. Injection site tenderness was very mild at the IXCHIQ application site for the next 2 days. The tenderness, was moderate at the other vaccine injection sites on 26-NOV-2024 but had almost resolved at the time of below events. Between midnight and 3am on 28-NOV-2024, after a day and evening of desk work and while sitting at the desk, the consumer developed moderate musculoskeletal pain of an overall dull but somewhat burning character. At the same time, there he noted an increase in injection site pain for IXCHIQ. It was most pronounced between shoulder blades and on the proximal limbs (here most noticeable on the upper back of the thighs when sitting), but also on the distal upper limbs. There was no arthralgia. The pain persisted at rest but allowed to sleep before it escalated to severe during the day, preventing daily activties. Additional symptoms included mild malaise and mild headache; the latter was worsened by shaking the head. There was no fever or other systemic symptom. The adverse reactions were left untreated, decreased to moderate during 29-NOV-2024 and resolved on 30-NOV-2024. The reporter commented: Due to the identical temporal relationship and risk profile, all three vaccines are potentially to blame, however severe myalgia has been identified particularly as a common adverse reactition to IXCHIQ vaccine. Given my usually mild reactions to past vaccinations for influenza and COVID, which tended to occur within 24h of injection, as well as the impression of a delayed increase of injection site pain at the IXCHIQ injection site, I would assess IXCHIQ to be probably related, with COMIRNATY and FLUCELVAX as less likely alternative explanations. Outcome: Recovered; Sender's Comments: Causality assessed as possibly related for all reported events, as time to onset is plausible (within 3 days past vaccination) and as they are all well known for IXCHIQ directly or by medical concept, indicative of a local vaccination site reaction for the injection site tenderness and Injection site pain and indicative of a systemic vaccination reaction for Musculoskeletal pain, Malaise and Headache However, co-suspect vaccinations with Comirnaty and Flucelvax Trival on the same day should be taken into consideration, too.
Medical History/Concurrent Conditions: Influenza like illness (Past reaction to drug); Injection site pain (Past reaction to drug); Nasopharyngitis