Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | Unknown | — |
Gone through the vaccine procedure twice, but her titers has been coming back at 0.1 iu/mL, below the required 0.5 iu/mL; Case reference number US-BN-2025-001723 is a spontaneous case initially received from a consumer via Bavarian Nordic (reference number: CASE-000420) on 23-Oct-2025 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, a couple of months ago, the patient was bitten by bat. On an unspecified date, unknown of time after bat bite, as reported the patient gone through the procedure twice with RabAvert vaccine along with its reconstitution parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at an unknown dose, route, and site of administration, for indication post-exposure vaccination. On an unspecified date, the patient's titers had been coming back at 0.1 iu/mL, below the required 0.5 iu/mL. At the time of the initial report, it was unknown if the patient recovered from the event of 'antibody result abnormal'. The reporter assessed the event of 'antibody result abnormal' as non-serious, however the event is assessed as serious due to seriousness criteria of other medically important condition, and the causality was not reported. No further information provided.; Reporter's Comments: A female patient of unknown age had a serious event of antibody test abnormal (other medically important condition) on an unspecified date, an unknown amount of time after patient gone through the procedure twice with RabAvert vaccine for indication post-exposure vaccination. Antibody test abnormal is unlisted and unexpected for RabAvert per CCDS v6 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Biological plausibility is theoretically plausible, since RabAvert is intended to affect antibody levels, but causality assessment cannot be more meaningful without temporal data. There is insufficient information for a proper causality assessment, however, the causality for antibody test abnormal is considered as unlikely related. For regulatory reporting purposes, this case is considered reportable.; Sender's Comments: A female patient of unknown age had a serious event of antibody test abnormal (other medically important condition) on an unspecified date, an unknown amount of time after patient gone through the procedure twice with RabAvert vaccine for indication post-exposure vaccination. Antibody test abnormal is unlisted and unexpected for RabAvert per CCDS v6 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Biological plausibility is theoretically plausible, since RabAvert is intended to affect antibody levels, but causality assessment cannot be more meaningful without temporal data. There is insufficient information for a proper causality assessment, however, the causality for antibody test abnormal is considered as unlikely related. For regulatory reporting purposes, this case is considered reportable.
Comments: None.
Test Name: rabies antibodies; Result Unstructured Data: Test Result:/ ;0.1 iu/mL; Comments: /