Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | Unknown | — |
Rabies titers continue to be persistently low, potential lack of efficacy; Rabies titers continue to be persistently low, potential lack of efficacy; Case reference number US-BN-2025-001687 is a spontaneous case initially received from physician via Bavarian-Nordic (reference number: CASE-000303) on 16-Oct-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, as reported, the patient received all the doses of 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 unknown indication. On an unspecified date, the patient received all the doses of HRIG (immunoglobulin human anti-rabies; batch number: unknown), at an unknown dose, route, site of administration for an unknown indication. On an unspecified date, unknown time after vaccination with RabAvert the patient's rabies titers continue to be persistently low and had potential lack of efficacy. At the time of the initial report, it was unknown if the patient recovered from the event of 'antibody result abnormal' and 'lack of drug effect'. The reporter did not provide seriousness and causality assessment for the events of 'lack of drug effect' and 'antibody result abnormal', however the event of 'lack of drug effect' was assessed as serious due to the criteria of medical significance. No further information was provided.; Reporter's Comments: A female patient of unspecified age experienced a serious event of drug ineffective (medical significance), and a non-serious event of antibody test abnormal on an unspecified date, unknown time after the patient received all the doses of RabAvert vaccine for unknown indication, as the patient's rabies titers continued to be persistently low and the patient had potential lack of efficacy. Antibody test abnormal is unlisted and unexpected for RabAvert per CCDS v6 and USPI, and drug ineffective is considered as listed per company convention. The outcome was unknown. The patient's medical history, concurrent diseases and concomitant medication details were not provided. There was no information on similar events in the context of or independent from previous immunizations. There is no information on temporal relationship between immunization and events, nor of the presence of confounding factors or alternative explanations. 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 unspecified age experienced a serious event of drug ineffective (medical significance), and a non-serious event of antibody test abnormal on an unspecified date, unknown time after the patient received all the doses of RabAvert vaccine for unknown indication, as the patient's rabies titers continued to be persistently low and the patient had potential lack of efficacy. Antibody test abnormal is unlisted and unexpected for RabAvert per CCDS v6 and USPI, and drug ineffective is considered as listed per company convention. The outcome was unknown. The patient's medical history, concurrent diseases and concomitant medication details were not provided. There was no information on similar events in the context of or independent from previous immunizations. There is no information on temporal relationship between immunization and events, nor of the presence of confounding factors or alternative explanations. 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.
HRIG
Test Name: rabies antibodies; Result Unstructured Data: Test Result:/ ;Persistently low.; Comments: /