Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 3 | FDP00824 | IM / LA |
The patient received the second dose of RabAvert eight days after the first dose and third dose 22 days after the first dose; Rash on lower back that itches and burns; Redness and rash noted across lower back; Rash on lower back that itches and burns; Rash on lower back that itches and burns; Case reference number US-BN-2026-000746 is a spontaneous case initially received from other health professional (Bavarian Nordic reference number: BN-2026-00071) on 08-May-2026 and concerns a *27-year-old* male patient. The patient's medical history and concomitant medication details were not provided. *On 13-Apr-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: FDP00824; expiration date: 31-Jan-2029), at a dose of 1 mL, intramuscularly in the left arm for rabies immunization*. *On 21-Apr-2026, eight days after the 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: FDP00824; expiration date: 31-Jan-2029), at a dose of 1 mL, intramuscularly in the right arm (explicitly coded as 'inappropriate schedule of vaccine administered').* On 05-May-2026, 22 days after the first dose, the patient received *the third* dose of RabAvert vaccine along with its reconstitution parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: *FDP00825; expiration date: 31-Jan-2029*), at a dose *of 1 mL, intramuscularly in the left arm (explicitly coded as 'inappropriate schedule of vaccine administered').* *It was reported that there were no deviations or issues during the administration of RabAvert. * On 07-May-2026, *two days after the third dose*, reported as this morning, the patient experienced a rash on lower back that itches and burns, as well as redness across lower back. As reported, the patient did not feel sick. *On the same day*, the patient *recovered* from the events of 'skin rash', 'redness', 'burning skin' and 'itchy rash'. *It was reported that there were no complications during recovery from the events. * The reporter *assessed* the events of 'skin rash', 'redness', 'burning skin' and 'itchy rash as non-serious, *mild in intensity* and possibly related to RabAvert vaccine. * Additional information received via Bavarian Nordic on 11-May-2026 included: confirmation of the county of occurrence and that it is not a duplicate case. 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 20-May-2026: New information included RabAvert dosing information, patient's demographic information, events information (seriousness, severity, start date, stop date, outcome and causality for the events), confirmation that there were no deviations or issues during the administration of the RabAvert vaccine, and confirmation that there were no complications during recovery from the events.; Reporter's Comments: A spontaneous case for a 27-year male patient received RabAvert vaccine for rabies immunization. He received the second dose of RabAvert 8 days later which was considered inappropriate schedule of vaccine administered. On 05-May-2026, 22 days after the first dose, the patient received the third dose of RabAvert vaccine. Two days later, on 07 May 2026, the patient developed a lower back rash with associated itching, burning, and redness, without systemic symptoms. The event rash is expected whereas burning of skin and itching are unexpected as per CCDS V6.0 and SmPC. The event of inappropriate schedule of vaccine administered is considered listed per company conventions. The medical history and concomitant medication details were not provided. At the time of the follow up report, the patient recovered from the events of rash, erythema, skin burning sensation, and pruritic rash and no complications occurred during recovery. The company agrees with the reporter's causality assessment of the events as possibly related to the suspect vaccine as a temporal association exists between the vaccination and the onset of events. However, without further historical, clinical, and pharmacological information, a definitive causal link cannot be established. The event of inappropriate schedule of vaccine administered is assessed as not related to suspect product but to human factor. The case is non-serious. For regulatory reporting purposes, this case is considered related.; Sender's Comments: A spontaneous case for a 27-year male patient received RabAvert vaccine for rabies immunization. He received the second dose of RabAvert 8 days later which was considered inappropriate schedule of vaccine administered. On 05-May-2026, 22 days after the first dose, the patient received the third dose of RabAvert vaccine. Two days later, on 07 May 2026, the patient developed a lower back rash with associated itching, burning, and redness, without systemic symptoms. The event rash is expected whereas burning of skin and itching are unexpected as per CCDS V6.0 and SmPC. The event of inappropriate schedule of vaccine administered is considered listed per company conventions. The medical history and concomitant medication details were not provided. At the time of the follow up report, the patient recovered from the events of rash, erythema, skin burning sensation, and pruritic rash and no complications occurred during recovery. The company agrees with the reporter's causality assessment of the events as possibly related to the suspect vaccine as a temporal association exists between the vaccination and the onset of events. However, without further historical, clinical, and pharmacological information, a definitive causal link cannot be established. The event of inappropriate schedule of vaccine administered is assessed as not related to suspect product but to human factor. The case is non-serious. For regulatory reporting purposes, this case is considered related.
Comments: None.