Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | FDP00824 | IM / RA |
itching at the injection site; tenderness at the site; Case reference number US-BN-2026-000699 is a spontaneous case initially received from other health professional and received via agency (reference number: BN-2026-00062) on 29-Apr-2026 and concerns a *44-year-old* male patient. The patient's medical history and concomitant medication details were not provided. On *27-Apr-2026*, the patient received *the first* dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: *FDP00824; expiration date: 31-Jan-2029*), at dose *of 1 mL, intramuscularly in the right arm for indication reported as rabies immunization program.* On *the same day*, the patient experienced *mild* itching at the injection site for about three to four hours and *mild* tenderness at the injection site when the patient returned from the center *for about three to four hours*. The patient denies any other symptoms. *On the same day, after approximately three to four hours, the patient recovered from the events of 'injection site itching' and 'injection site tenderness'. It was reported that there were not any complications during recovery from the events and that vaccination with RabAvert did not interrupt due to events.* *On 04-May-2026, seven days after the first dose, the patient received the second dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00825; expiration date: 31-Jan-2029), at dose of 1 mL, intramuscularly in the right arm.* *It was reported that the same or similar events did not occur after administration of the second dose.* The reporter *assessed* the events of 'injection site itching' and 'injection site tenderness' *as non-serious and possibly related to RabAvert vaccine*. Additional information received from Bavarian Nordic on 30-Apr-2026 included reference number. All follow up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information was received from other health professional on 13-May-2026: New information included RabAvert dosing information, patient's demographic information, seriousness, severity, start date, stop date, outcome and causality for the events, confirmation that there were no any complications during recovery from the events, confirmation that vaccination with RabAvert was not interrupted due to the events, and confirmation that same or similar events did not occur after administration of the next dose.; Reporter's Comments: This spontaneous case concerns a 44-year-old male patient who experienced the non-serious events of injection site pruritus and injection site pain on the same day when he received the first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution, at dose of 1 mL, intramuscularly in the right arm for indication reported as rabies immunization program. Injection site pruritus and injection site pain are listed and expected for RabAvert per CCDS v6 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was resolved. Considering plausible temporal relationship, biological plausibility and insufficient information regarding presence of confounding factors or alternative explanations, the causality for these events is assessed as possibly related to the suspect vaccine. The case is non-serious. For regulatory reporting purposes, this case is considered related.; Sender's Comments: This spontaneous case concerns a 44-year-old male patient who experienced the non-serious events of injection site pruritus and injection site pain on the same day when he received the first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution, at dose of 1 mL, intramuscularly in the right arm for indication reported as rabies immunization program. Injection site pruritus and injection site pain are listed and expected for RabAvert per CCDS v6 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was resolved. Considering plausible temporal relationship, biological plausibility and insufficient information regarding presence of confounding factors or alternative explanations, the causality for these events is assessed as possibly related to the suspect vaccine. The case is non-serious. For regulatory reporting purposes, this case is considered related.
Comments: None.