Received Apr 1, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| CHIK | CHIKUNGUNYA (VIMKUNYA) | BAVARIAN NORDIC | UNK | Unknown | — |
Patient arm is still sore after a month; Patient got the vaccine and it was the most painful one that patient ever gotten; Bruise lasted for weeks; Case reference number US-BN-2026-000178 is a spontaneous case initially received from other health professional via Bavarian Nordic (reference number: US-CHIK-2500029) on 30-Jan-2026 and concerns a patient of an unknown age and gender. The patient's medical history and concomitant medication were not provided. On an unspecified date, the patient received a dose of Vimkunya vaccine along with its reconstitution part prefilled syringe (batch number: unknown), at an unknown dose, route or site of administration for unknown indication. Patient reported it was the most painful one ever. On an unspecified date, the patient had bruise which lasted for weeks, and patient arm was still sore after a month. At the time of initial report, it was unknown if the patient was recovered from the events of pain in extremity, pain and contusion. The reporter did not provide the seriousness criteria and did not provide a causality assessment for events pain in extremity, pain and contusion. Additional information received from other health care professional on 02-Feb-2026, included confirmation for country of occurrence.; Reporter's Comments: A patient of an unknown age and gender experienced non-serious events of pain, bruise and arm was sore on an unspecified date, an unknown amount of time after the patient received a dose of Vimkunya vaccine for unknown indication. Pain in extremity, pain and contusion are unlisted and unexpected for Vimkunya. The patient's medical history and concomitant medication were not provided. The outcome was unknown. Considering implied temporal relationship, biological plausibility and insufficient information regarding presence of confounding factors or alternative explanations, the causality is assessed as related to the suspect vaccine. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.; Sender's Comments: A patient of an unknown age and gender experienced non-serious events of pain, bruise and arm was sore on an unspecified date, an unknown amount of time after the patient received a dose of Vimkunya vaccine for unknown indication. Pain in extremity, pain and contusion are unlisted and unexpected for Vimkunya. The patient's medical history and concomitant medication were not provided. The outcome was unknown. Considering implied temporal relationship, biological plausibility and insufficient information regarding presence of confounding factors or alternative explanations, the causality is assessed as related to the suspect vaccine. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.
Comments: None.