Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | FDP00824 | IM / RA |
Dizzy; Redness at injection site; Tenderness at injection site; Case reference number US-BN-2026-000721 is a spontaneous case report initially received from other health professional on 30-Apr-2026 from Bavarian Nordic via agency (reference number: BN-2026-00063) and concerns a *27-year-old* female patient. The patient's medical history and concomitant medication details were not provided. On 29-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 rabies immunization*. On the same date, reported as an hour after leaving centre, the patient experienced dizzy. The patient also experienced redness and tenderness at the injection site. *On the same day, approximately one hour after the beginning of the events*, the patient *recovered* from the events of 'dizzy', 'injection site redness' and 'injection site tenderness'. *On 06-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*. The reporter *assessed* the events of 'dizzy', 'injection site redness' and 'injection site tenderness' *as non-serious, mild in intensity, and possibly related to RabAvert*. Additional information received from Bavarian Nordic on 01-May-2026: New information included reference number. Additional information received from Bavarian Nordic on 05-May-2026: New information included country 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 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.; Reporter's Comments: A 27-year-old female patient experienced dizziness, redness at injection site and tenderness at injection site, on the same day when she 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 rabies immunization. The outcome was resolved. Dizziness, injection site erythema and injection site pain are all listed and expected per CCDS v6 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was resolved. Dizziness, injection site erythema and injection site pain are all assessed as possibly related due to plausible temporal relationship, known product safety profile, lack of alternative explanation and since contributory role of suspect product cannot be excluded. The case is non-serious.; Sender's Comments: A 27-year-old female patient experienced dizziness, redness at injection site and tenderness at injection site, on the same day when she 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 rabies immunization. The outcome was resolved. Dizziness, injection site erythema and injection site pain are all listed and expected per CCDS v6 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was resolved. Dizziness, injection site erythema and injection site pain are all assessed as possibly related due to plausible temporal relationship, known product safety profile, lack of alternative explanation and since contributory role of suspect product cannot be excluded. The case is non-serious.
Comments: None.