Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | Unknown | — |
The patient's titers show a levels that were non-protective; Case reference number US-BN-2026-000235 is a spontaneous case initially received from pharmacist via Bavarian Nordic (reference number: CASE-002029) on 09-Feb-2026 and concerns a patient of unknown gender and age. The patient's medical history was not provided. The patient's concomitant medication included chemotherapeutics (unspecified). On an unknown date, the patient received the dose of RabAvert vaccine along with its reconstitution parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at an unknown dose, site or route administration for unknown indication. On an unspecified date, as reported, the patient's titers show a level that were non-protective. At the time of the initial report, it was unknown if the patient recovered from the event 'antibody result abnormal'. The reporter did not provide the seriousness and causality assessment for the event 'antibody result abnormal'. No further information was provided.; Reporter's Comments: A patient of unknown gender and age received the dose of RabAvert vaccine for unknown indication. Reportedly, on an unspecified date, the patient's titers show a level that were non-protective. Antibody test abnormal is unlisted and unexpected for RabAvert per CCDS v6 and USPI. The patient's medical history was not provided, and concomitant medication included chemotherapeutics (unspecified). 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. Considering concomitant chemotherapy could be more probable cause of inadequate immune response, the causality for antibody test abnormal is considered as unlikely related. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.; Sender's Comments: A patient of unknown gender and age received the dose of RabAvert vaccine for unknown indication. Reportedly, on an unspecified date, the patient's titers show a level that were non-protective. Antibody test abnormal is unlisted and unexpected for RabAvert per CCDS v6 and USPI. The patient's medical history was not provided, and concomitant medication included chemotherapeutics (unspecified). 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. Considering concomitant chemotherapy could be more probable cause of inadequate immune response, the causality for antibody test abnormal is considered as unlikely related. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.
Comments: None.