Received Jun 3, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| CHIK | CHIKUNGUNYA (VIMKUNYA) | BAVARIAN NORDIC | UNK | Unknown | — |
pain due to improper administration; Patient felt a bit fizzy; felt a tad off; improper administration; Case reference number US-BN-2026-000289 is a spontaneous case initially received from a consumer via agency (reference number: US-VIM-2500041) on 17-Feb-2026 and concerns a patient of an unknown age and gender. The patient's medical history included reactions to flu shots (in 1980's). The patient's concomitant medications details not provided. On an unspecified date, the patient received a dose of Vimkunya along with prefilled syringe (batch number: unknown) at an unknown dose, site or route of administration, for an unknown indication. On an unspecified date, reportedly first day after vaccination, the patient experienced feeling fizzy and *felt a tad off for a part of a day* and take a nap. On an unspecified date, an unknown amount of time after the first dose, the patient experienced pain, reported as most likely due to improper administration than content (explicitly coded ' incorrect product administration technique'). On an unspecified date, the patient reportedly felt 'all good' and recovered from the event of *'feeling abnormal'* and however the outcome of the event 'pain' was unknown. The reporter did not provide seriousness assessment for the events of 'pain' and *'feeling abnormal'*. The reporter assessed 'pain ' as unlikely related to Vimkunya and did not provide causality assessment for the event of *'feeling abnormal'*. Additional information was received from agency on 18-Feb-2026. New information included: confirmation on reporter's country. All follow up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information was received from agency via social media on 24-Feb-2026: New information included updated event verbatim, coding and event outcome.; Reporter's Comments: This case concerns a patient of an unknown age and gender, who experienced non-serious event of feeling abnormal, on unspecified date (reportedly first day) after receiving a dose of Vimkunya for an unknown indication. On unspecified date, patient experienced pain and which is most likely due to improper administration, which is considered as pain and wrong technique in product usage process. Pain and feeling abnormal are unlisted and unexpected per CCDS v1 and USPI. Event wrong technique in product usage process is considered as listed per company convention The patient's medical history included reactions to flu shots and concomitant medication details were not provided. Outcome was recovered from feeling abnormal and unknown for pain. Considering implied temporal relationship, biological plausibility and insufficient information regarding presence of confounding factors or alternative explanations, the causality for event feeling abnormal is assessed as possibly related to the suspect vaccine. For event pain it is assessed as not related as it is not due to the suspect drug, but it is because of wrong technique. Event wrong technique in product usage process is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.; Sender's Comments: This case concerns a patient of an unknown age and gender, who experienced non-serious event of feeling abnormal, on unspecified date (reportedly first day) after receiving a dose of Vimkunya for an unknown indication. On unspecified date, patient experienced pain and which is most likely due to improper administration, which is considered as pain and wrong technique in product usage process. Pain and feeling abnormal are unlisted and unexpected per CCDS v1 and USPI. Event wrong technique in product usage process is considered as listed per company convention The patient's medical history included reactions to flu shots and concomitant medication details were not provided. Outcome was recovered from feeling abnormal and unknown for pain. Considering implied temporal relationship, biological plausibility and insufficient information regarding presence of confounding factors or alternative explanations, the causality for event feeling abnormal is assessed as possibly related to the suspect vaccine. For event pain it is assessed as not related as it is not due to the suspect drug, but it is because of wrong technique. Event wrong technique in product usage process is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.
Medical History/Concurrent Conditions: Vaccination adverse reaction