Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | FDP00756 | IM / RA |
The second dose of RabAvert was administered ten days after the first dose; Nausea; Case reference number US-BN-2026-000280 is a spontaneous case initially received from other health professional via agency (reference number: BN-2026-00032) on 16-Feb-2026 and concerns a 45-years-old female patient. The patient's medical history and concomitant medication details were not provided. On 13-Feb-2026, the patient received the first dose of RabAvert vaccine along with its reconstitution parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00756, expiry: 30-Nov-2028), at dose of 1 ml, intramuscularly in the right arm for indication reported as rabies immunization program. On 13-Feb-2026, at 16:15, the patient experienced nausea. *On 13-Feb-2026, at 16:25, the patient recovered from the event of nausea.* On 23-Feb-2026, ten days after first dose, the patient received the second dose of RabAvert vaccine along with its reconstitution parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00756, expiry: 30-Nov-2028), at dose of 1 ml, intramuscularly in the left arm (explicitly coded as 'inappropriate schedule of vaccine administered'). The reporter assessed the event of nausea as non-serious and possibly related to RabAvert. Additional information received via Bavarian Nordic Safety on 17-Feb-2026 and included country, city and state of occurrence. All follow up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information was received from Bavarian Nordic on 04-Mar-2026: New information included event details (seriousness, causality, severity, end date), RabAvert dosing information, additional event and patient demographics. Follow-up information was received from consumer on 19-Mar-2026: New information included dosing information, event outcome for 'nausea'.; Reporter's Comments: This case concerns a 45-years-old female patient, who experienced non-serious event of nausea, on the same day after the patient received a dose of RabAvert vaccine for an indication of rabies immunization program. As reported patient received the second dose of RabAvert, 10 days after the first dose, which is considered as inappropriate schedule of product administered. Nausea is listed and expected for RabAvert per CCDS v6 and USPI. Inappropriate schedule of product administered is considered as listed as per company convention. The patient's medical history and concomitant medication details was not provided. Outcome was recovered. Considering implied temporal relationship, biological plausibility and insufficient information regarding presence of confounding factors or alternative explanations, the causality is assessed as possibly related to the suspect vaccine. Inappropriate schedule of product administered is not related to the suspect product, but to the human error. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.; Sender's Comments: This case concerns a 45-years-old female patient, who experienced non-serious event of nausea, on the same day after the patient received a dose of RabAvert vaccine for an indication of rabies immunization program. As reported patient received the second dose of RabAvert, 10 days after the first dose, which is considered as inappropriate schedule of product administered. Nausea is listed and expected for RabAvert per CCDS v6 and USPI. Inappropriate schedule of product administered is considered as listed as per company convention. The patient's medical history and concomitant medication details was not provided. Outcome was recovered. Considering implied temporal relationship, biological plausibility and insufficient information regarding presence of confounding factors or alternative explanations, the causality is assessed as possibly related to the suspect vaccine. Inappropriate schedule of product administered is not related to the suspect product, but to the human error. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.
Comments: None.